Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 12 units of Comprehensive Shoulder System Primary Shoulder Stem (Micro Length, Porous Plasma, 14 MM, 55 MM Long, Item Number 113614, Lot Number 439470) distributed worldwide in the United States, Canada, Ecuador, and the Netherlands. The recalled products underwent an incorrect rework operation on their porous plasma sprayed coating. Internal testing found that these parts may not have sufficient adhesion strength because the waterjet rework process used is not validated for products that were coated by an outside vendor.
The source document does not specify a remedy or instructions for what affected consumers should do.
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: 12 units Lot/code info: Lot Number: 439470 UDI: (01)00880304554153(17) 290803(10)439470
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.