FDA Device recall Z-1960-2019
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509 by Zimmer Biomet, citing lack of an adequate sterilization validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1960-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-10 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Reason
Lack of an adequate sterilization validation.
Identifiers
| code_info | Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083…Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340 |
|---|
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-1960-2019%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.