Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 11 units of Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long (Item Number 113631) from Lot Number 821860. The products underwent an incorrect rework operation on their porous plasma sprayed coating. Internal testing found that the parts may not have sufficient adhesion strength because they were reworked using a waterjet process that has not been validated for products with vendor-applied coatings.
The affected products were distributed worldwide, including in the United States, Canada, Ecuador, and the Netherlands. The record does not specify a remedy or what action affected consumers should take.
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: 11 units Lot/code info: Lot Number: 821860 UDI: (01)00880304462687(17) 290522(10)821860
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.