Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 19 units of the Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma, Size A, 60 MM due to a manufacturing defect. The affected products underwent an incorrect rework operation on their porous plasma sprayed coating, and internal testing showed the parts may not have sufficient adhesion strength. The problem occurred when products that were coated by a vendor were then reworked using an internal waterjet process that has not been validated for vendor-coated products. The recalled units are from Lot Numbers 853650 and 853810 and were distributed worldwide, including in the United States, Canada, Ecuador, and the Netherlands.
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.
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Reason for recall: The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands. Quantity: 19 units Lot/code info: Lot Number: 853650, 853810 UDI: (01)00880304468030(17) 290122(10)853650; (01)00880304468030(17) 290211(10)853810
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.