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Open, Classified

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

FDA Recall Z-1509-2022 · Posted None

Recalling FirmCorin Ltd
Recall StatusOpen, Classified
Product CodeJDI
Date Initiated2022-07-22
Product Quantity5 devices

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.

Firm Action

The firm notified its direct consignees of the recall on 07/22/2022 by letter. The notice explained the issue and requested the following actions: "Actions to be taken by the Customer: - Quarantine the devices if not yet performed - Return the devices to Corin Limited, displaying the RGA note on the exterior of the parcel, to: RA/Vigilance Department; Corin Ltd; Corinium Centre; Cirencester; Gloucestershire; GL7 1YJ, United-Kingdom - Complete the acknowledgement of receipt and forward it to the Vigilance department of Corin UK to confirm receipt of this Field Safety Notice/Recall letter."

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of OK, TX, FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153381Corin Metafix Hip StemCorin U.S.A. Limited · 2016-01-21K082525CORIN METAFIX FEMORAL STEMCorin USA · 2010-02-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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