FDA Recall
Open, Classified
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Recall: Z-0113-2024
·
Initiated September 15, 2023
Recall
- Recall Number
- Z-0113-2024
- Event Number
- 93051
- Firm
- Tornier, Inc
- FEI Number
- 3000718467
- Product Code
- PHX
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- September 15, 2023
- Posted
- October 13, 2023
- Address
- 10801 Nesbitt Ave S, Bloomington, MN, 55437-3109
Description
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.
Action
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.
Distribution
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Quantity
30 units