Device product
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Z-0113-2024
Product summary
- Firm
- Tornier, Inc
- Event
- Event 93051
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0113-2024
Official wording
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.
Code information: UDI/DI 10846832062017, Lot Number 1756123
Distribution pattern: US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Derived failure modes
-
Unknown
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.