FDA Device recall Z-0113-2024
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- FDA Device
- Class II
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 by Tornier, citing one lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0113-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-15 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tornier |
| Distribution | CA, CO, IL, MA, MN, NC, OR, RI, SC, TN |
Product
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Reason
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
Identifiers
| code_info | UDI/DI 10846832062017, Lot Number 1756123 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0113-2024%22
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