Recall Z-0113-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
Tornier, Inc
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
| Date | Oct 13, 2023 (initiated Sep 15, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| 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. |
| Quantity | 30 units |
| Distribution | US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc., Nov 15, 2016 |