Biomet, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0674-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 7, 2022

Date Posted: March 2, 2022

Recall Number: Z-0674-2022

Event ID: 89544

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.

Status: Terminated

Product Quantity: 11 units

Code Information:

Lot Number: 821860 UDI: (01)00880304462687(17) 290522(10)821860

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated