FDA Device recall Z-2820-2018
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem by Zimmer Biomet, citing 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 repl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2820-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, GA, IL, MO, NY, VA |
Product
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Reason
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.
Identifiers
| code_info | lot 621550 UDI (01)00880304474154(17)280206(10)621550 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2820-2018%22
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