Exactech, Inc.
48 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Exactech, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-10FDA-DeviceClass IIExactech 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 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
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).
- 2024-04-10FDA-DeviceClass IIExactech 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 Number 314-02-04, Shoulder Arthroplasty
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).
- 2024-04-10FDA-DeviceClass IIExactech 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 Number 314-01-14, Shoulder Arthroplasty
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).
- 2024-04-10FDA-DeviceClass IIExactech 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, Item Number 314-01-04, Shoulder Arthroplasty
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).
- 2023-12-27FDA-DeviceClass IIExactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech 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) 02-024-35-2509, l) 02-024-35-2510, m) 02-024-35-2511, n) 02-024-35-2512, o) 02-024-35-3010, p) 02-024-35-3011, q) 02-024-35-3012, r) 02-024-35-3013, s) 02-024-35-3513, t) 02-024-35-3515, u) 02-024-35-4012,
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Novation Hip System, Catalog Numbers: 134-36-45
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIExactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-12-27FDA-DeviceClass IIAcuMatch Hip System, Catalog Number 142-32-27
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
- 2023-07-05FDA-DeviceClass IIExactech Ergo Impactor Handle, Catalog #321-09-05.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
- 2023-07-05FDA-DeviceClass IIExactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
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