ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Reported: August 22, 2018 Initiated: June 8, 2018 #Z-2820-2018
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.
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? ▼
ARCOS Modular Revision Hip System, item number 11-300814 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-2820-2018.
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