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Recall Observatory FDA recall evidence

Device product

ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.

Z-2820-2018

June 08, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80534
Status
Terminated
Classification
Class II
Quantity
12
Official record key
device-enforcement:Z-2820-2018

Official wording

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.

Code information: lot 621550 UDI (01)00880304474154(17)280206(10)621550

Distribution pattern: US distribution to CA, GA, IL, MO, NY, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.