Recall Z-0579-2024
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 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
Codes / lots: a) 320-36-00, GTIN 10885862086617, Serial Numbers: A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641; b) 320-36-03, GTIN 10885862086624, Serial Numbers: A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122; c) 320-36-04, GTIN 10885862086624, Serial Numbers: A685325; d) 320-36-10, GTIN 10885862086631, Serial Numbers: A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137…
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-0579-2024
- Initiated
- November 21, 2023
- Posted by FDA
- January 18, 2024
- Product code
- KWT – Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- 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-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-0586-2024 Class II | Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, 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-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 |