Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
This recall is currently active, issued July 22, 2022. It was issued by Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom.
- Recall Initiated
- July 22, 2022
- Recall Number
- Z-1509-2022
- Quantity
- 5 devices
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of OK, TX, FL.
Lot / Code Info
UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Root Cause
Process control
Action Taken
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."