Z-2820-2018 Class II Terminated
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
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 Pattern
US distribution to CA, GA, IL, MO, NY, and VA.
Code Information
lot 621550 UDI (01)00880304474154(17)280206(10)621550