Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
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, 18 MM, 55 MM Long (Item Number 113618) from Lot Number 732370. The products underwent an incorrect rework operation on their porous plasma sprayed coating using a waterjet process that was not validated for vendor-coated products. Internal testing indicated the parts may not have sufficient adhesion strength as a result.
The affected products were distributed worldwide, including throughout the United States, Canada, Ecuador, and the Netherlands. The recall notice does not specify a remedy or recommended action for 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: 12 units Lot/code info: Lot Number: 732370 UDI: (01)00880304554191(17) 290802(10)732370
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.