Device product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Z-2265-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 88304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2265-2021
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 : 934870 (01)00880304474024(17)310419(10)934870
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