Comprehensive Shoulder System Mini Humeral Stem 9mm — Class II medical device recall Z-1543-2020
Terminated recall by Biomet, Inc., reported 2020-04-01. A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
| Recall number | Z-1543-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-02-17 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2022-05-31 |
| Countries outside the US | CA, JP, KR, NL |
| Quantity | 14 units |
| UPC / GTIN / UDI-DI | 00880304462649 |
| Lot numbers | 659260 |
| Model numbers | 113629 |
Product
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
Reason for recall
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
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-1543-2020. 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.