Z-2259-2021 Class II Terminated
FDA device recall Z-2259-2021 was initiated by Biomet, Inc. on June 2, 2021 and is designated Class II. Reason for recall: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention The recall status is terminated (terminated July 6, 2022). Affected quantity: 88 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 2, 2021
- Termination Date
- July 6, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Reason for Recall
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Distribution Pattern
US Nationwide distribution.
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