Recall Z-0586-2024
Exactech, Inc. · initiated November 21, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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) 02-024-35-2509, 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, v) 02-024-35-4013, w) 02-024-35-4510, x) 02-024-35-4515, y) 02-024-35-5011, z) 02-024-35-5012, aa) 02-024-44-1511, bb) 02-024-44-2009, cc) 02-024-44-2011, dd) 02-024-44-2015, ee) 02-024-44-2510, ff) 02-024-44-2515, gg) 02-024-44-3009, hh) 02-024-44-3011, ii) 02-024-44-3013, jj) 02-024-44-3015, kk) 02-024-44-3509, ll) 02-024-44-4009, mm) 02-024-44-4509, nn) 02-024-44-4511, oo) 02-024-44-4512, pp) 02-024-44-4513, qq) 02-024-44-5013
Codes / lots: a) 02-023-02-0029, GTIN 10885862596376, Serial Numbers: A704613, A704614, A704618, A704633, A704634, A704649, A704651, A704632; b) 02-023-02-0032, GTIN 10885862596383, Serial Numbers: A703837, A703844, A703847, A703863, A704084, A704089, A704100, A704102, A704105, A704110, A704111, A704115, A704142, A704161, A704162, A704167, A704171, A704189, A704190, A704151, A704156, A704183; c) 02-023-02-0035, GTIN 10885862596390, Serial Numbers: A704258, A704282, A704299, A704300, A704306, A704314, A704320; d) 02-023-02-0038, GTIN 10885862596406, Serial Numbers: A704222, A704229, A704231, A704233, 704240, A704249; e) 02-024-35-1512, GTIN 10885862596741, Serial Numbers: A713224, A713230, A713233, A713234, A713237; f) 02-024-35-1515, GTIN 10885862596772, Serial Numbers: A697051; g) 02-024-35-1519, GTIN 10885862596796, Serial Numbers: A713345; h) 02-024-35-2010, GTIN 10885862596819, Serial Numbers: A701145, A701149, A701150, A701151, A701152, A701153, A701154, A701155, A701156, A701157, A701158, A701159, A701160, A701162, A701163, A701164, A701165, A701166; i) 02-024-35-2013, GTIN 10885862596840, Serial Numbers: A697420, A697421, A697423, A697424, A697425, A697427, A697428, A697430, A697431…
Reason for recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA-determined cause: Packaging change control
Action taken
Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Details
- Recall number
- Z-0586-2024
- Initiated
- November 21, 2023
- Posted by FDA
- January 18, 2024
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Distribution
- US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0577-2024 Class II | AcuMatch Hip System, Catalog Number 142-32-27Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0578-2024 Class II | Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0579-2024 Class II | Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0580-2024 Class II | Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0581-2024 Class II | Exactech Novation Hip System, Catalog Numbers: 134-36-45Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0582-2024 Class II | Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0583-2024 Class II | Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0584-2024 Class II | Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0585-2024 Class II | Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0587-2024 Class II | Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |
| Z-0588-2024 Class II | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | 11/21/2023Open, Classified |