FDA recall Z-1509-2022

Corin Ltd · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2022-07-22
Report date
2022-08-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cirencester, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2022