Recall Z-1667-2022— Corin Ltd

Name: FDA recall Z-1667-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-12

Class II · Completed

Class II FDA medical device recall by Corin Ltd, initiated 2022-07-12. It names one FDA 510(k) clearance: K142761. Product: 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..

Recalling firm: Corin Ltd
Classification: Class II
Status: Completed
Initiated: 2022-07-12
Firm location: Cirencester, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K142761 — Corin TaperFit Hip StemCorin USA·cleared 2015-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.