Z-0113-2024 Class II Ongoing
FDA device recall Z-0113-2024 was initiated by Tornier, Inc on September 15, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- September 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
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.
Distribution Pattern
US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Code Information
UDI/DI 10846832062017, Lot Number 1756123