FDA Device recall Z-2231-2019
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 by Zimmer Biomet, citing cleaning processes potentially being ineffective.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2231-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-02 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH, OK, OR, SC, TX |
Product
Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
Reason
Cleaning processes potentially being ineffective
Identifiers
| code_info | Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019. |
|---|
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-2231-2019%22
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