Recall Z-1509-2022— Corin Ltd

Name: FDA recall Z-1509-2022
Creator: U.S. Food and Drug Administration
Published: 2022-07-22

Class II · Ongoing

Class II FDA medical device recall by Corin Ltd, initiated 2022-07-22. It names 2 FDA 510(k) clearances: K153381, K082525. Product: Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103. Reason: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630..

Recalling firm: Corin Ltd
Classification: Class II
Status: Ongoing
Initiated: 2022-07-22
Firm location: Cirencester, United Kingdom

510(k) clearances named in this recall

2 on FDA's record

K153381 — Corin Metafix Hip StemCorin U.S.A. Limited·cleared 2016-01-21
K082525 — CORIN METAFIX FEMORAL STEMCorin USA·cleared 2010-02-04

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

Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103

Reason for recall

One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.

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