Recall Z-1883-2024 · PHX Shoulder Prosthesis, Reverse Configuration
Tornier S.A.S.
Stryker Blueprint Software, Catalog #BPUE001.
| Date | May 22, 2024 (initiated Apr 16, 2024) |
| Status | Open, Classified |
| Reason | The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval. |
| Root cause | Software change control |
| Action | The firm issued letters via email on 4/16/2024. The email provided the issue and risks and said that for additional information regarding risks, exact incompatible configuration details, and steps for you to take, please refer to the attached document. The email listed a requested action, which was to review the case information provided on the business acknowledgment form, confirm the final implants used in this surgery, and complete and sign the response form on Page 4 at their earliest convenience. The attached Urgent Medical Device Recall letter was dated 16-April-2024 and provided the |
| Distribution | US Nationwide distribution in the states of FL, KY, NJ, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation Tornier, Inc., Nov 12, 2021 |