OPTETRAK One Peg Patella — Class II medical device recall Z-2156-2024
Ongoing recall by Exactech, Inc., reported 2024-06-26. Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components p
| Recall number | Z-2156-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2024-04-18 |
| Classified | 2024-06-18 |
| Reported by FDA | 2024-06-26 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10885862039637, 10885862039644, 10885862039651, 10885862039668, 10885862039675, 10885862039682 |
| Lot numbers | 6276425, 6276426, 6276428, 6276429, 6276433, 6276434, 6276435, 6276437, 6276440, 6276442, 6276443, 6276445, 6276446, 6276447, 6276448, 6276449, 6276450, 6276451, 6276452, 6276453, 6385266, 6385268, 6385269, 6385272, 6385273, 6385274, 6385277, 6385278, 6385281, 6385285, 6385286, 6385294, 6385300, 6385304, 6385307, 6385310, 6385316, 6385318, 6385319, 6385321 and 98 more |
Product
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Reason for recall
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2156-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.