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Recall Observatory FDA recall evidence

Device product

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635

Z-0677-2022

January 07, 2022

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 89544
Status
Terminated
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-0677-2022

Official wording

Reason: 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.

Code information: Lot Number: 396250 UDI: (01)00880304462663(17)281121(10)396250

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.