FDA recall Z-1850-2021

Product

Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. 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-1850-2021