Device product

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312

Z-2264-2021

June 02, 2021

Class II

Product summary

Firm: Biomet, Inc.
Event: Event 88304
Status: Terminated
Classification: Class II
Quantity: 33 units
Official record key: device-enforcement:Z-2264-2021

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 : 678950 (01)00880304474093(17)310416(10)678950 880250 (01)00880304474093(17)310422(10)880250 880790 (01)00880304474093(17)310331(10)880790

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