Device product
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Z-1667-2022
Product summary
- Firm
- Corin Ltd
- Event
- Event 90662
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1667-2022
Official wording
Reason: Some of the devices did not pass fatigue testing.
Code information: Model #588.3800, Lot #494754; UDI 05055343871065
Distribution pattern: Distribution was made to NJ. There was no military/government distribution.
Derived failure modes
-
Unknown
Some of the devices did not pass fatigue testing.