stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
This recall is currently active, issued October 13, 2023. It was issued by Tornier, Inc.
- Company
- Tornier, Inc
- Recall Initiated
- September 15, 2023
- Posted
- October 13, 2023
- Recall Number
- Z-0113-2024
- Quantity
- 30 units
- Firm Location
- Bloomington, MN
- Official Source
- View on FDA website ↗
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
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Lot / Code Info
UDI/DI 10846832062017, Lot Number 1756123
Root Cause
Process change control
Action Taken
Stryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.