Z-0675-2022 Class II Terminated
FDA device recall Z-0675-2022 was initiated by Biomet, Inc. on Jan 7, 2022 and is designated Class II. 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… The recall status is terminated (terminated Apr 13, 2023). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2022
- Initiation Date
- Jan 7, 2022
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0675-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026