Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 11 units of its Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long (Item Number: 113635) from Lot Number 396250. The products underwent an incorrect rework operation on the porous plasma sprayed coating. Internal testing found that the 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 affected devices were distributed worldwide, including throughout the United States and in Canada, Ecuador, and the Netherlands. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
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: 396250 UDI: (01)00880304462663(17)281121(10)396250
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.