Z-1667-2022 Class II Ongoing

Recalled by Corin Ltd — Cirencester

Recall Details

Product Type
Devices
Report Date
September 7, 2022
Initiation Date
July 12, 2022
Termination Date
N/A
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