FDA Enforcement
Class II
Ongoing
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Recall: Z-1509-2022
·
Reported August 17, 2022
Enforcement
- Recall Number
- Z-1509-2022
- Event ID
- 90573
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Corin Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 17, 2022
- Initiation Date
- July 22, 2022
- Classification Date
- August 9, 2022
- Address
- Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom
Description
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.
Code Info
UDI (01) 0 505563 89123 0 (10) 485630 (17) 261114, Lot Number 485630
Distribution
US Nationwide distribution in the states of OK, TX, FL.
Quantity
5 devices