Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 81 units of the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM nationwide. The recalled devices could potentially develop chatter in the inner taper, leading to fretting corrosion and device failure that may require surgical intervention to address.
The affected units are identified by seven specific lot numbers: 004230, 626590, 626600, 678840, 679170, 679180, and 880170. The recall record does not specify a remedy or recommended action for affected consumers.
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: 81 units Lot/code info: Lot Numbers/UDI : 004230 (01)00880304473799(17)310412(10)004230 626590 (01)00880304473799(17)310312(10)626590 626600 (01)00880304473799(17)310314(10)626600 678840 (01)00880304473799(17)310305(10)678840 679170 (01)00880304473799(17)310423(10)679170 679180 (01)00880304473799(17)310318(10)679180 880170 (01)00880304473799(17)310409(10)880170
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.