Device product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Z-2262-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 88304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 units
- Official record key
device-enforcement:Z-2262-2021
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 : 004230 (01)00880304473799(17)310412(10)004230 626590 (01)00880304473799(17)310312(10)626590 626600 (01)00880304473799(17)310314(10)626600 678840 (01)00880304473799(17)310305(10)678840 679170 (01)00880304473799(17)310423(10)679170 679180 (01)00880304473799(17)310318(10)679180 880170 (01)00880304473799(17)310409(10)880170
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention