FDA recall Z-2259-2021

Biomet, Inc. · Class II · device

Product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300

Reason for recall

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2021-06-02
Report date: 2021-08-18
Termination date: 2022-07-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2021