FDA Device recall Z-2762-2019
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is d…
- FDA Device
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is d… by Zimmer, citing incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2762-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer |
| Distribution | US |
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
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Identifiers
| code_info | Lot # 2941696 UDI: (01) 00889024415973 (17) 280299 (10) 2941696 |
|---|
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-2762-2019%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.