FDA Enforcement
Class II
Terminated
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Recall: Z-1667-2022
·
Reported September 7, 2022
Enforcement
- Recall Number
- Z-1667-2022
- Event ID
- 90662
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Corin Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 7, 2022
- Initiation Date
- July 12, 2022
- Classification Date
- August 31, 2022
- Termination Date
- May 4, 2026
- Address
- Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom
Description
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Reason
Some of the devices did not pass fatigue testing.
Code Info
Model #588.3800, Lot #494754; UDI 05055343871065
Distribution
Distribution was made to NJ. There was no military/government distribution.
Quantity
1