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Recall Observatory FDA recall evidence

Device product

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335

Z-2272-2021

June 02, 2021

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 88304
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2272-2021

Official wording

Reason: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Code information: Lot Numbers/UDI : 881130 (01)00880304480483(17)310418(10)881130

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention