Data Foundry

Medical device recalls 2018

ECHO Bi-Metric Hip System — Class II medical device recall Z-2821-2018

Terminated recall by Zimmer Biomet, Inc., reported 2018-08-22, distributed in CA, GA, IL, MO, NY, VA. Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential

Recall numberZ-2821-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated2018-06-08
Classified2018-08-14
Reported by FDA2018-08-22
Terminated2020-04-14
DistributedCA, GA, IL, MO, NY, VA
Quantity12
UPC / GTIN / UDI-DI00880304463370
Lot numbers944680
Model numbers192414

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2821-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.