Zimmer Biomet Comprehensive Segmental Revision System — Class II medical device recall Z-1173-2018
Terminated recall by Biomet, Inc., reported 2018-04-04, distributed nationwide. During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with
| Recall number | Z-1173-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-02-28 |
| Classified | 2018-03-23 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 634 |
| UPC / GTIN / UDI-DI | 00880304850316, 00880304850330 |
| Lot numbers | 019600, 028450, 028460, 033700, 040470, 053800, 053810, 062210, 062220, 062830, 095580, 098020, 110780, 110790, 119120, 119130, 130020, 130040, 130070, 142530, 155900, 155910, 157180, 160770, 160780, 162450, 162460, 185590, 185620, 185630, 192770, 196660, 201270, 203520, 231490, 241160, 241180, 241190, 241230, 241290 and 147 more |
| Model numbers | 211250, 211251, 211252, 211253, 211254, 211255 |
Product
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
Reason for recall
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
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-1173-2018. 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.