--- title: "DePuy Orthopaedics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search DePuy Orthopaedics, 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/depuy-orthopaedics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # DePuy Orthopaedics, Inc. recall records **8** reported ongoing 19 records in this archive. Latest source date Mar 12, 2024. 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 Mar 12, 2024 FDA device enforcement ### [ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.](https://isitonrecall.com/recall/fda-device-z-1456-2024-attune-affixium-cementless-fixed-bearing-knee-with-3dp-technology-size-6-component-of-the-attune-tot/) Product incorrectly labelled. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada. [Official source for ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUN...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1456-2024%22) Feb 15, 2023 FDA device enforcement ### [Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118](https://isitonrecall.com/recall/fda-device-z-1263-2023-attune-revision-limb-preservation-system-lps-tibial-insert-xxsm-18mm-part-number-151760118/) The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand [Official source for Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1263-2023%22) Feb 15, 2023 FDA device enforcement ### [Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212](https://isitonrecall.com/recall/fda-device-z-1264-2023-attune-revision-limb-preservation-system-lps-tibial-insert-xsm-12mm-part-number-151760212/) The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand [Official source for Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1264-2023%22) Feb 15, 2023 FDA device enforcement ### [Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226](https://isitonrecall.com/recall/fda-device-z-1265-2023-attune-revision-limb-preservation-system-lps-tibial-insert-xsm-26mm-part-number-151760226/) The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand [Official source for Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1265-2023%22) Feb 15, 2023 FDA device enforcement ### [Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312](https://isitonrecall.com/recall/fda-device-z-1266-2023-attune-revision-limb-preservation-system-lps-tibial-insert-sm-12mm-part-number-151760312/) The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand [Official source for Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1266-2023%22) Feb 15, 2023 FDA device enforcement ### [Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507](https://isitonrecall.com/recall/fda-device-z-1267-2023-attune-posterior-ps-fixed-bearing-fb-tibial-insert-sz5-7mm-part-number-151640507/) The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand [Official source for Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1267-2023%22) Jun 29, 2022 FDA device enforcement ### [ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525](https://isitonrecall.com/recall/fda-device-z-1419-2022-attune-measured-sizing-and-rotation-guide-to-size-the-femur-and-align-rotation-of-the-bone-cuts-in-p/) Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteol... Class II Reported ongoing Distribution: Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong,... [Official source for ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts i...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1419-2022%22) May 18, 2022 FDA device enforcement ### [MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 13634...](https://isitonrecall.com/recall/fda-device-z-1375-2022-modular-cathcart-fracture-head-hip-ball-sizes-41mm-to-60mm-inclusive-metallic-femoral-head-prosthesi/) The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using ... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Ze... [Official source for MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head pros...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1375-2022%22) Mar 11, 2022 FDA device enforcement ### [VELYS Robotic-Assisted Solution Base Product No.: 451570100](https://isitonrecall.com/recall/fda-device-z-1029-2022-velys-robotic-assisted-solution-base-product-no-451570100/) System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand. [Official source for VELYS Robotic-Assisted Solution Base Product No.: 451570100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1029-2022%22) Jan 5, 2022 FDA device enforcement ### [ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003](https://isitonrecall.com/recall/fda-device-z-0631-2022-attune-revision-posterior-femoral-augment-sz-9-12mm-intended-as-a-component-in-total-knee-arthroplas/) May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. Class II Reported terminated Distribution: US Nationwide distribution in the states of TN, TX. [Official source for ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthrop...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0631-2022%22) Jan 5, 2022 FDA device enforcement ### [ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001](https://isitonrecall.com/recall/fda-device-z-0632-2022-attune-revision-distal-femoral-augment-sz-6-4mm-intended-as-a-component-in-total-knee-arthroplasty-t/) May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. Class II Reported terminated Distribution: US Nationwide distribution in the states of TN, TX. [Official source for ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplas...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0632-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610](https://isitonrecall.com/recall/fda-device-z-0483-2022-global-unite-std-stem-sz-6-part-number-11000610/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0483-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100](https://isitonrecall.com/recall/fda-device-z-0484-2022-global-unite-std-stem-sz-8-part-number-110008100/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0484-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600](https://isitonrecall.com/recall/fda-device-z-0485-2022-global-unite-rev-stem-sz-8-part-number-110008600/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0485-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100](https://isitonrecall.com/recall/fda-device-z-0486-2022-global-unite-std-stem-sz-10-part-number-110010100/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0486-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600](https://isitonrecall.com/recall/fda-device-z-0487-2022-global-unite-rev-stem-sz-10-product-code-110010600/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0487-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100](https://isitonrecall.com/recall/fda-device-z-0488-2022-global-unite-std-stem-sz-12-product-code-110012100/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0488-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100](https://isitonrecall.com/recall/fda-device-z-0489-2022-global-unite-std-stem-sz-14-product-code-110014100/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2022%22) Dec 7, 2021 FDA device enforcement ### [GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100](https://isitonrecall.com/recall/fda-device-z-0490-2022-global-unite-std-stem-sz-16-product-code-110016100/) Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage Class II Reported terminated Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Neth... [Official source for GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0490-2022%22) ## Reasons in these listed records - Product incorrectly labelled. - The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. - Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mec... - The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a... These examples come from this result page and are not a ranking of every recall reason. ## Checking DePuy Orthopaedics, Inc. ### Is there a recall on depuy orthopaedics, inc. right now? This archive contains 19 records, including 8 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 DePuy Orthopaedics, Inc.](https://isitonrecall.com/check/?q=DePuy%20Orthopaedics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)