Manufacturer

Exactech, Inc.

97 recalls in our database name Exactech, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 97

ModerateFDA (Devices)·Z-0586-2024·2023-12-27
Exactech knee replacement inserts recalled for vacuum seal loss
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Product
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2050-2023·2023-07-05
Exactech Shoulder GPS Impactor Handle Recalled for Locking Mechanism Defect
Exactech is recalling 250 units of its Shoulder GPS Impactor Handle due to a defect where the ball and spring in the locking mechanism can dislodge during disassembly or impaction. The defect could affect the device's function during surgical use.
Product
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2051-2023·2023-07-05
Exactech Ergo Impactor Handle Recalled for Component Dislodgement
Exactech Ergo Impactor Handles are recalled because the ball and spring in the locking mechanism may dislodge during disassembly or use. Approximately 784 devices are affected.
Product
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-1730-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk
Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1725-2022·2022-09-21
GXL Acetabular Hip Implant Liners Recalled Due to Packaging Defect
Exactech is recalling specific GXL acetabular hip implant liners due to non-conforming packaging that may cause accelerated device wear. The recall affects 1,017 devices distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1732-2022·2022-09-21
Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear
Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags
Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1731-2022·2022-09-21
GXL Acetabular Liners Packaged Improperly May Experience Accelerated Wear
Exactech is recalling certain GXL acetabular hip implant liners because non-conforming packaging may cause accelerated wear. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 countries.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1726-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Improper Packaging and Accelerated Wear
Exactech is recalling 136 GXL acetabular liners used in hip implants due to non-conforming packaging that may cause accelerated wear. The devices were distributed worldwide to multiple countries.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2022·2022-09-21
GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear
Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1733-2022·2022-09-21
GXL Hip Implant Liners Recalled for Packaging Defect Risk
Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1729-2022·2022-09-21
GXL Acetabular Liners Recalled Due to Non-Conforming Packaging
Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2022·2021-10-13
ARTHROFOCUS Polyethylene Tibial Inserts recalled for packaging defect
Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.
Product
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2022·2021-10-13
Knee replacement system inserts recalled for missing oxygen barrier in packaging
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2022·2021-10-13
TRULIANT Knee System tibial inserts recalled for packaging oxygen barrier defect
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
Product
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Insert
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2022·2021-10-13
Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging
Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2022·2021-10-13
OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
Product
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0024-2022·2021-10-13
Vantage Total Ankle System Recalled for Inadequate Packaging Barriers
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.
Product
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0022-2022·2021-10-13
OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect
Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.
Product
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2022·2021-10-13
Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging
Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0019-2022·2021-10-13
OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier
Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.
Product
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2251-2021·2021-08-18
Exactech hip prosthesis femoral head labeling and marking discrepancy
Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2250-2021·2021-08-18
Exactech BIOLOX Delta Femoral Head Hip Prosthesis Recalled for Device Marking Mismatch
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
Product
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2021·2021-07-28
Exactech Connexion GXL Hip Implant Liners Risk Premature Wear
Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.
Product
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
Category
Medical Device
Distribution
Distributed nationwide