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.
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small,
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, I
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
April 10, 2024Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 3
Hazard: 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 Ethylene Vinyl Alcohol (EVOH).
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011,
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Novation Hip System, Catalog Numbers: 134-36-45
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls AcuMatch Hip System, Catalog Number 142-32-27
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
July 5, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Ergo Impactor Handle, Catalog #321-09-05.
Hazard: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
July 5, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Hazard: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
September 21, 2022Medical DevicesFDA
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM,
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. ALL POLYETHYLENE ACETABULAR CUP,
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. NOVATION GXL LINER NEUTRAL, 32MM
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. GXL NEUTRAL LINER, G0 28MM ID, 13
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. NOVATION CONSTRAINED LINER 28MM
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. NOVATION GXL LINER, NEUTRAL, 28MM
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 GXL 0 DEGREE LINER 28MM
Hazard: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.