Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 33 units of the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM nationwide. The recalled hip system components could potentially develop chatter in the inner taper, leading to fretting corrosion and device failure while in use, which may require surgical intervention to address.
The affected devices are identified by three specific lot numbers: 678950, 880250, and 880790. The source document does not specify a remedy or recommended course of action for consumers who may have received this product.
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: 33 units Lot/code info: Lot Numbers/UDI : 678950 (01)00880304474093(17)310416(10)678950 880250 (01)00880304474093(17)310422(10)880250 880790 (01)00880304474093(17)310331(10)880790
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.