stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Reported: October 25, 2023 Initiated: September 15, 2023 #Z-0113-2024
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.
Details
- Recalling Firm
- Tornier, Inc
- Units Affected
- 30 units
- Distribution
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
- Location
- Bloomington, MN
Frequently Asked Questions
What product was recalled? ▼
stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502. Recalled by Tornier, Inc. Units affected: 30 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2023. Severity: Moderate. Recall number: Z-0113-2024.
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