Trabecular Metal Reverse Shoulder System — Class II medical device recall Z-0299-2020
Terminated recall by Zimmer Biomet, Inc., reported 2019-11-13, distributed nationwide. Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
| Recall number | Z-0299-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-10-10 |
| Classified | 2019-11-07 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 5,459,583 devices |
| Model numbers | 00430900103, 00434210613, 00434210813, 00434210817, 00434210913, 00434211013, 00434211017, 00434211113, 00434211213, 00434211217, 00434211313, 00434211413, 00434211417, 00434211513, 00434211613, 00434211713, 00434211813, 00434810613, 00434810813, 00434810817, 00434810913, 00434811013, 00434811017, 00434811113, 00434811213 and 42 more |
Product
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 00434211413 00434211417 00434211513 00434211613 00434211713 00434211813 00434810613 00434810813 00434810817 00434810913 00434811013 00434811017 00434811113 00434811213 00434811217 00434811313 00434811413 00434811417 00434811513 00434811613 00434811713 00434811813 00434900813 00434900817 00434901013 00434901017 00434901213 00434901217 00434901413 00434903700 00434903811 00434903909 00434903912 32855090339 32855090353 32855090368 32855090375 32855090395 32855090512 32855090519 32855090520 32855090531 32855090585 32855090593 32855090598 32855090599 32855090628 32855090636 32855090637 32855090640 32855090658 32855090659 32855090734 47430703100 47430704100 47430706100
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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-0299-2020. 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.