Device product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301

Z-2260-2021

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-2260-2021

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 : Lot Number UDI Number 626490 (01)00880304468030(17)310412(10)626490 679210 (01)00880304468030(17)310418(10)679210

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