FDA recall Z-1851-2021

Corin Ltd · Class II · device

Product

Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.

Reason for recall

Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status
Terminated
Initiation date
2021-05-06
Report date
2021-06-23
Termination date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cirencester, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2021