FDA recall Z-2268-2021

Product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322

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-2268-2021