Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling 9 units of its Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long (Item Number 113633) from Lot Number 994800. The products underwent an incorrect rework operation on their porous plasma sprayed coating using an internal waterjet process that has not been validated for vendor-coated products. Internal testing showed that these parts may not have sufficient adhesion strength as a result of this improper rework.
The affected products were distributed worldwide, including throughout the United States, Canada, Ecuador, and the Netherlands. The source document does not specify a remedy or instructions 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: 9 units Lot/code info: Lot Number: 994800 UDI:(01)00880304462632(17)290816(10)994800
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.