Device product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302

Z-2261-2021

June 02, 2021

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 88304
Status: Terminated
Classification: Class II
Quantity: 21 units
Official record key: device-enforcement:Z-2261-2021

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 : 626540 (01)00880304474123(17)310423(10)626540 679320 (01)00880304474123(17)310419(10)679320

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