Recall Z-3309-2024 · PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Tornier, Inc
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
| Date | Sep 27, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. |
| Root cause | Under Investigation by firm |
| Action | Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: memphis.fieldaction@stryker.com. |
| Quantity | 38 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201315 | PERFORM Humeral System Stem Tornier, Inc., Sep 11, 2020 |