Z-1667-2022 Class II Terminated
FDA device recall Z-1667-2022 was initiated by Corin Ltd on July 12, 2022 and is designated Class II. Reason for recall: Some of the devices did not pass fatigue testing. The recall status is terminated (terminated May 4, 2026). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- September 7, 2022
- Initiation Date
- July 12, 2022
- Termination Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Reason for Recall
Some of the devices did not pass fatigue testing.
Distribution Pattern
Distribution was made to NJ. There was no military/government distribution.
Code Information
Model #588.3800, Lot #494754; UDI 05055343871065