Exactech Recalls
211 recalls on record · August 1, 2012 to March 18, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 21, 2022Medical DevicesFDA
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36
Hazard: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
September 21, 2022Medical DevicesFDA
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ
Hazard: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
September 21, 2022Medical DevicesFDA
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER S
Hazard: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech r
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX).
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX,
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Insert
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Pro
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX,
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
October 13, 2021Medical DevicesFDA
Exactech, Inc. recalls OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, wit
Hazard: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
August 18, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Hazard: Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
August 18, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Hazard: Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-22-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.