Medical DeviceMar 18, 2026
Equinoxe Ergo Ergo Modular Impactor Handle recall — FDA Z-1509-2026
Impactor handle may be missing cross-pin
Class IIFDA: OngoingExactech, Inc.
Recall history in this database
Classification mix: Class II: 113.
Medical DeviceMar 18, 2026
Equinoxe Core Instrument Kit recall — FDA Z-1510-2026
Impactor handle may be missing cross-pin
Class IIFDA: OngoingExactech, Inc.
Medical DeviceNov 26, 2025
Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm recall — FDA Z-0536-2026
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 IIFDA: OngoingExactech, Inc.
Medical DeviceNov 26, 2025
Equinoxe Ergo Ergo Augments Pilot Tip Converter recall — FDA Z-0537-2026
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 IIFDA: OngoingExactech, Inc.
Medical DeviceNov 26, 2025
Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm recall — FDA Z-0535-2026
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 IIFDA: OngoingExactech, Inc.
Medical DeviceSep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 recall — FDA Z-2562-2025
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceSep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER recall — FDA Z-2561-2025
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceFeb 19, 2025
Exactech AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM recall — FDA Z-1165-2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceFeb 19, 2025
Exactech Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM recall — FDA Z-1166-2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceFeb 19, 2025
Exactech Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM recall — FDA Z-1167-2025
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceJul 10, 2024
Exactech Acumatch L-Series BIPOLAR LINER, 22mm recall — FDA Z-2236-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceJun 26, 2024
Exactech OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM recall — FDA Z-2157-2024
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceJun 26, 2024
Exactech OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM recall — FDA Z-2155-2024
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceJun 26, 2024
Exactech OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM recall — FDA Z-2158-2024
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceJun 26, 2024
Exactech OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM recall — FDA Z-2156-2024
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY recall — FDA Z-1409-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38 recall — FDA Z-1407-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13 recall — FDA Z-1421-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number recall — FDA Z-1425-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03 recall — FDA Z-1420-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head recall — FDA Z-1413-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41 recall — FDA Z-1415-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small recall — FDA Z-1405-2024
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…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature recall — FDA Z-1404-2024
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…
Class IIFDA: OngoingExactech, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Exactech, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.