Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 88 units of the Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM (Item Number: 11-301300) distributed nationwide in the United States. The proximal cone bodies in these devices could potentially experience chatter and inner taper fretting corrosion, which may lead to device failure and require surgical intervention.
The recall affects devices with the following lot numbers: 626440, 626450, 626460, 626890, 678370, 678770, 678800, and 695830. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
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: US Nationwide distribution. Quantity: 88 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.