PlainRecalls
FDA Devices Moderate Class II Terminated

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633

Reported: March 2, 2022 Initiated: January 7, 2022 #Z-0676-2022

Product Description

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633

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.

Details

Recalling Firm
Biomet, Inc.
Units Affected
9 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633. Recalled by Biomet, Inc.. Units affected: 9 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2022. Severity: Moderate. Recall number: Z-0676-2022.

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