Recall Z-0773-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
Tornier, Inc
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
| Date | Jan 19, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | The incorrect device is contained in the labeled package. |
| Root cause | Packaging process control |
| Action | The recalling firm issued letters dated 1/3/2024 via email to sales representatives and distributors and via FedEx to hospitals on 1/3/2024. The letter provided a product description, product issue, potential risks including a photo of the device that should be in the package and a photo of the device that was in the package. The customer actions needed included: (1) Immediately check the inventory for the affected product, remove it from the point of use, and isolate/quarantine it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email to confirm receipt of |
| Quantity | 50 |
| Distribution | Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid Tornier, Inc., Jan 30, 2019 |