PlainRecalls
FDA Devices Moderate Class II Terminated

ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

Reported: August 22, 2018 Initiated: June 8, 2018 #Z-2821-2018

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
12
Distribution
US distribution to CA, GA, IL, MO, NY, and VA.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem. Recalled by Zimmer Biomet, Inc.. Units affected: 12.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2821-2018.