Recall Z-1509-2022
Corin Ltd · initiated July 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Codes / lots: UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
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.
FDA-determined 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."
Details
- Recall number
- Z-1509-2022
- Initiated
- July 22, 2022
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 5 devices
- Distribution
- US Nationwide distribution in the states of OK, TX, FL.
- Recalling firm
- Corin Ltd, Cirencester