medical Class II Updated 2022-03-02

Biomet, Inc. recalls Comprehensive Shoulder System Mini Humeral Stem, Porous Plas

Recalled Product

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 821860 UDI: (01)00880304462687(17) 290522(10)821860
View official government recall

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