stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
FDA device recall Z-0113-2024 · posted 2023-10-13 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 30 units
- Distribution
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
- Date initiated
- 2023-09-15
- Date posted
- 2023-10-13
- Location
- Bloomington, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742) | Tornier, Inc. | 2016-11-15 |