Sidus Stem-Free Shoulder Humeral Head — Class II medical device recall Z-0300-2020
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-0300-2020 |
|---|---|
| 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 | 0104555380, 0104555400, 0104555420, 0104555440, 0104555460, 0104555480, 0104555485, 0104555500, 0104555505, 0104555520, 0104555525 |
Product
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
Reason for recall
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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-0300-2020. 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.