Device product
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Z-3309-2024
Product summary
- Firm
- Tornier, Inc
- Event
- Event 95245
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 units
- Official record key
device-enforcement:Z-3309-2024
Official wording
Reason: 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.
Code information: GTIN 00846832084494, Batch Lot # 1495AY
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.