Z-3309-2024 Class II Ongoing
FDA device recall Z-3309-2024 was initiated by Tornier, Inc on August 29, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 38 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2024
- Initiation Date
- August 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
Product Description
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 00846832084494, Batch Lot # 1495AY