Device product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
Z-2275-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 88304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2275-2021
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 : 880960 (01)00880304474307(17)310504(10)880960
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