Device product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322

Z-2268-2021

June 02, 2021

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 88304
Status: Terminated
Classification: Class II
Quantity: 11 units
Official record key: device-enforcement:Z-2268-2021

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 : 678990 (01)00880304473751(17)310407(10)678990

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