Z-2821-2018 Class II Terminated
FDA device recall Z-2821-2018 was initiated by Zimmer Biomet, Inc. on Jun 8, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 14, 2020). Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 22, 2018
- Initiation Date
- Jun 8, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2821-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026