Z-0113-2024 Class II Ongoing

Recalled by Tornier, Inc — Bloomington, MN

Recall Details

Product Type
Devices
Report Date
October 25, 2023
Initiation Date
September 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units

Product Description

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Reason for Recall

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.

Distribution Pattern

US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN

Code Information

UDI/DI 10846832062017, Lot Number 1756123