Humeral Stem 83mm — Class II medical device recall Z-0979-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-21, distributed nationwide. Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were
| Recall number | Z-0979-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-12-08 |
| Classified | 2018-03-13 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00880304462632 |
Product
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Reason for recall
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
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-0979-2018. 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.