FDA recall Z-0652-2022

Howmedica Osteonics Corp. · Class II · device

Product

Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440

Reason for recall

There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.

Distribution

The product was distributed to the following US states: MI

Key facts

Status
Terminated
Initiation date
2021-12-30
Report date
2022-02-23
Termination date
2024-03-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2022