FDA Device recall Z-0300-2020
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 01…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 01… by Zimmer Biomet, citing non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0300-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-10 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
Reason
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Identifiers
| code_info | All product manufactured prior to January 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0300-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.