Z-2821-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
August 22, 2018
Initiation Date
June 8, 2018
Termination Date
April 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12

Product Description

ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. 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 Pattern

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

Code Information

lot 944680. UDI (01)00880304463370(17)280206(10)944680