Device product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Z-2259-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 88304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-2259-2021
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 : 626440 (01)00880304474611(17)310409(10)626440 626450 (01)00880304474611(17)310322(10)626450 626460 (01)00880304474611(17)310402(10)626460 626890 (01)00880304474611(17)310323(10)626890 678370 (01)00880304474611(17)310419(10)678370 678770 (01)00880304474611(17)310419(10)678770 678800 (01)00880304474611(17)310409(10)678800 695830 (01)00880304474611(17)310412(10)695830
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