FDA Device recall Z-0590-2019
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 by Zimmer Biomet, citing zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation deter….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0590-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-10 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | IN, MD, MO, MS, NM |
Product
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Reason
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
Identifiers
| code_info | 068390 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0590-2019%22
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