FDA recall Z-2820-2018

Product

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Reason for recall

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

Distribution

US distribution to CA, GA, IL, MO, NY, and VA.

Key facts

Status

Terminated

Initiation date

2018-06-08

Report date

2018-08-22

Termination date

2020-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2820-2018