Z-0675-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 2, 2022
- Initiation Date
- January 7, 2022
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Code Information
Lot Number: 327160 UDI: (01)00880304449749(17)290819(10)327160