--- title: "Zimmer, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Zimmer, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/zimmer-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Zimmer, Inc. recall records **70** reported ongoing 71 records in this archive. Latest source date May 20, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 20, 2026 FDA device enforcement ### [Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240](https://isitonrecall.com/recall/fda-device-z-2527-2026-off-axis-comprehensive-shoulder-system-small-augment-off-axis-reamer-guide-model-catalog-number-1100/) Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Numb...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2527-2026%22) May 20, 2026 FDA device enforcement ### [Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241](https://isitonrecall.com/recall/fda-device-z-2528-2026-off-axis-comprehensive-shoulder-system-medium-augment-off-axis-reamer-guide-model-catalog-number-110/) Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Num...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2528-2026%22) May 20, 2026 FDA device enforcement ### [Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242](https://isitonrecall.com/recall/fda-device-z-2529-2026-off-axis-comprehensive-shoulder-system-large-augment-off-axis-reamer-guide-model-catalog-number-1100/) Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Numb...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2529-2026%22) May 20, 2026 FDA device enforcement ### [Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444](https://isitonrecall.com/recall/fda-device-z-2530-2026-off-axis-alliance-glenoid-left-4-peg-augment-reamer-guide-model-catalog-number-110040444/) Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2530-2026%22) May 20, 2026 FDA device enforcement ### [Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476](https://isitonrecall.com/recall/fda-device-z-2531-2026-off-axis-alliance-glenoid-right-4-peg-augment-reamer-guide-model-catalog-number-110040476/) Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2531-2026%22) May 11, 2026 FDA device enforcement ### [Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Descript...](https://isitonrecall.com/recall/fda-device-z-2578-2026-brand-name-persona-revision-product-name-persona-revision-trabecular-metal-femoral-distal-augment-mo/) Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. Class II Reported ongoing Distribution: Refer to the attached ZFA 2026-00088\_Initial Consignee List and ZFA 2026-00088\_Initial Distribution History containing the distribution and the identification of the affected co... [Official source for Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Aug...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2578-2026%22) Mar 30, 2026 FDA device enforcement ### [Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bow...](https://isitonrecall.com/recall/fda-device-z-1946-2026-brand-name-disposable-mixing-bowls-with-spatula-product-name-mixing-bowl-and-spatula-model-catalog-n/) Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI ... [Official source for Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Cata...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1946-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0967-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0967-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0968-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0968-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0969-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0969-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0970-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0970-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0971-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0971-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0972-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0972-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0973-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0973-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0974-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0974-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0975-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0975-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0976-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0976-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0977-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0977-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0978-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0978-2026%22) Dec 2, 2025 FDA device enforcement ### [Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Aff...](https://isitonrecall.com/recall/fda-device-z-0979-2026-brand-name-affixus-antegrade-femoral-nailing-system-product-name-affixus-antegrade-femoral-nails-mod/) Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunio... Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. [Official source for Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nail...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0979-2026%22) ## Reasons in these listed records - Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. - Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. - Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading t... - Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage ... These examples come from this result page and are not a ranking of every recall reason. ## Checking Zimmer, Inc. ### Is there a recall on zimmer, inc. right now? This archive contains 71 records, including 70 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Zimmer, Inc.](https://isitonrecall.com/check/?q=Zimmer%2C%20Inc.) 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