Comprehensive Shoulder System Primary Shoulder Stem recall
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
Why was Comprehensive Shoulder System Primary Shoulder Stem 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 821170 UDI: (01)00880304554122(17) 280825(10)821170
- Product
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
- Recalling firm
- Biomet, Inc.
- Quantity
- 10 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
- Recall date
- March 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)