BF Humeral Stem — Class II medical device recall Z-0298-2020
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-0298-2020 |
|---|---|
| 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 | 00430000606, 00430000613, 00430000706, 00430000713, 00430000813, 00430000817, 00430000820, 00430000913, 00430001013, 00430001017, 00430001020, 00430001113, 00430001213, 00430001217, 00430001220, 00430001313, 00430001413, 00430001417, 00430001420, 00430001513, 00430001613, 00430001713, 00430001813, 47430103100 |
Product
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Machine access
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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.