Recall Z-1509-2022 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Corin Ltd
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
| Date | Jul 22, 2022 |
| Status | Open, Classified |
| Reason | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. |
| Root cause | Process control |
| 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." |
| Quantity | 5 devices |
| Distribution | US Nationwide distribution in the states of OK, TX, FL. |
| FDA record | Open on fda.gov |