--- title: "Exactech, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Exactech, 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/exactech-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Exactech, Inc. recall records **63** reported ongoing 63 records in this archive. Latest source date Feb 3, 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 Feb 3, 2026 FDA device enforcement ### [Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05](https://isitonrecall.com/recall/fda-device-z-1509-2026-brand-name-equinoxe-ergo-product-name-ergo-modular-impactor-handle-model-catalog-number-321-09-05/) Impactor handle may be missing cross-pin Class II Reported ongoing Distribution: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emira... [Official source for Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1509-2026%22) Feb 3, 2026 FDA device enforcement ### [Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X](https://isitonrecall.com/recall/fda-device-z-1510-2026-brand-name-equinoxe-product-name-equinoxe-core-instrument-kit-model-catalog-number-kit-311x/) Impactor handle may be missing cross-pin Class II Reported ongoing Distribution: US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emira... [Official source for Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1510-2026%22) Sep 5, 2025 FDA device enforcement ### [Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component...](https://isitonrecall.com/recall/fda-device-z-0535-2026-brand-name-equinoxe-ergo-product-name-adjustable-angle-rtsa-reamer-42mm-model-catalog-number-321-59/) Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Class II Reported ongoing Distribution: U.S.: SC O.U.S.: N/A [Official source for Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0535-2026%22) Sep 5, 2025 FDA device enforcement ### [Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component...](https://isitonrecall.com/recall/fda-device-z-0536-2026-brand-name-equinoxe-ergo-product-name-adjustable-angle-rtsa-reamer-46mm-model-catalog-number-321-59/) Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Class II Reported ongoing Distribution: U.S.: SC O.U.S.: N/A [Official source for Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0536-2026%22) Sep 5, 2025 FDA device enforcement ### [Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Co...](https://isitonrecall.com/recall/fda-device-z-0537-2026-brand-name-equinoxe-ergo-product-name-ergo-augments-pilot-tip-converter-model-catalog-number-301-11/) Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. Class II Reported ongoing Distribution: U.S.: SC O.U.S.: N/A [Official source for Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0537-2026%22) Aug 15, 2025 FDA device enforcement ### [Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0...](https://isitonrecall.com/recall/fda-device-z-2561-2025-exactech-equinoxe-reverse-shoulder-humeral-liners-ref-320-38-00-145-deg-pe-38mm-hum-liner-0-320-38-0/) Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of A... [Official source for Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2561-2025%22) Aug 15, 2025 FDA device enforcement ### [Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM...](https://isitonrecall.com/recall/fda-device-z-2562-2025-exactech-equinoxe-reverse-shoulder-humeral-liners-322-38-00-145-deg-pe-38mm-hum-liner-0-ref-322-38-0/) Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of A... [Official source for Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2562-2025%22) Dec 31, 2024 FDA device enforcement ### [AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 1...](https://isitonrecall.com/recall/fda-device-z-1165-2025-acumatch-xle-item-number-product-description-140-28-27-am-ehxl-0-lnr-g-28mm-140-32-27-am-ehxl-0-lnr/) Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Reported ongoing Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain [Official source for AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1165-2025%22) Dec 31, 2024 FDA device enforcement ### [Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR...](https://isitonrecall.com/recall/fda-device-z-1166-2025-novation-xle-item-number-product-description-140-22-70-nv-ehxl-ntl-lnr-g00-22mm-140-28-50-nv-ehxlntr/) Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Reported ongoing Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain [Official source for Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV E...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1166-2025%22) Dec 31, 2024 FDA device enforcement ### [Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G...](https://isitonrecall.com/recall/fda-device-z-1167-2025-alteon-xle-item-number-product-description-140-22-70-nv-ehxl-ntl-lnr-g00-22mm-140-28-50-nv-ehxlntrl/) Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Class II Reported ongoing Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain [Official source for Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHX...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1167-2025%22) Apr 26, 2024 FDA device enforcement ### [Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-2...](https://isitonrecall.com/recall/fda-device-z-2236-2024-acumatch-l-series-bipolar-liner-22mm-bipolar-endoprosthesis-hip-item-numbers-a-100-22-19-sz-l-b-100/) The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density... Class II Reported ongoing Distribution: Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan. [Official source for Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2236-2024%22) Apr 18, 2024 FDA device enforcement ### [OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;](https://isitonrecall.com/recall/fda-device-z-2155-2024-optetrak-three-peg-patella-item-numbers-a-200-02-26-26mm-b-200-02-29-29mm-c-200-02-32-32mm-d-200-02/) Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class II Reported ongoing Distribution: Worldwide distribution. [Official source for OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2155-2024%22) Apr 18, 2024 FDA device enforcement ### [OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM](https://isitonrecall.com/recall/fda-device-z-2156-2024-optetrak-one-peg-patella-item-numbers-a-200-03-26-26mm-b-200-03-29-29mm-c-200-03-32-32mm-d-200-03-35/) Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class II Reported ongoing Distribution: Worldwide distribution. [Official source for OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2156-2024%22) Apr 18, 2024 FDA device enforcement ### [OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM](https://isitonrecall.com/recall/fda-device-z-2157-2024-optetrak-inset-patella-item-numbers-a-200-05-23-23mm-b-200-05-26-26mm-c-200-05-29-29mm/) Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class II Reported ongoing Distribution: Worldwide distribution. [Official source for OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2157-2024%22) Apr 18, 2024 FDA device enforcement ### [OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM](https://isitonrecall.com/recall/fda-device-z-2158-2024-optetrak-advanced-patella-3-peg-implant-item-numbers-a-200-07-26-26mm-b-200-07-29-29mm-c-200-07-32-3/) Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. Class II Reported ongoing Distribution: Worldwide distribution. [Official source for OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2158-2024%22) Mar 6, 2024 FDA device enforcement ### [Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Ite...](https://isitonrecall.com/recall/fda-device-z-1402-2024-exactech-equinoxe-glenoid-keeled-cemented-mates-with-38-41-44-head-alpha-curvature-sizes-a-small-ite/) The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylen... Class II Reported ongoing Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, M... [Official source for Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1402-2024%22) Mar 6, 2024 FDA device enforcement ### [Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item ...](https://isitonrecall.com/recall/fda-device-z-1403-2024-exactech-equinoxe-glenoid-keeled-cemented-mates-with-47-50-53-head-beta-curvature-sizes-a-small-item/) The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylen... Class II Reported ongoing Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, M... [Official source for Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1403-2024%22) Mar 6, 2024 FDA device enforcement ### [Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item ...](https://isitonrecall.com/recall/fda-device-z-1404-2024-exactech-equinoxe-glenoid-keeled-cemented-mates-with-47-50-53-head-beta-curvature-sizes-a-small-item/) The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylen... Class II Reported ongoing Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, M... [Official source for Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1404-2024%22) Mar 6, 2024 FDA device enforcement ### [Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-0...](https://isitonrecall.com/recall/fda-device-z-1405-2024-exactech-equinoxe-glenoid-keeled-cemented-47-50-53-head-beta-curvature-sizes-a-small-item-number-314/) The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylen... Class II Reported ongoing Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, M... [Official source for Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1405-2024%22) Mar 6, 2024 FDA device enforcement ### [Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item N...](https://isitonrecall.com/recall/fda-device-z-1406-2024-exactech-equinoxe-glenoid-posterior-augment-pegged-cemented-8o-left-mates-with-a-38-41-44-47-head-sm/) The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylen... Class II Reported ongoing Distribution: Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, M... [Official source for Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 4...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1406-2024%22) ## Reasons in these listed records - Impactor handle may be missing cross-pin - Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. - Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. - Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. These examples come from this result page and are not a ranking of every recall reason. ## Checking Exactech, Inc. ### Is there a recall on exactech, inc. right now? This archive contains 63 records, including 63 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 Exactech, Inc.](https://isitonrecall.com/check/?q=Exactech%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)