Device product

Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

Z-2269-2021

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-2269-2021

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 : 880850 (01)00880304480575(17)310412(10)880850

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