Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01 — Class II medical device recall Z-2762-2019
Terminated recall by Zimmer GmbH, reported 2019-10-09, distributed nationwide. Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant insi
| Recall number | Z-2762-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer GmbH, Winterthur, N/A, Switzerland |
| Recall initiated | 2019-08-21 |
| Classified | 2019-09-27 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CZ, DE, FR, GB |
| Quantity | 19 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024415973 |
| Lot numbers | 2941696 |
| Model numbers | 01.04555.500 |
Product
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
Reason for recall
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
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-2762-2019. 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.