Shoulder Implant Stem Recalled for Defective Coating Adhesion
Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an orthopedic implant with a structural defect—defective coating adhesion that could lead to implant failure. While no hospitalizations or injuries are reported, this represents a risk-of-harm product where the hazard is validated by internal testing but not yet manifested in patient harm.
Plain-English summary
Biomet, Inc. is recalling the Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long (Item Number: 113635, Lot Number: 396250) due to defective coating adhesion.
During internal testing, Biomet identified that parts coated with porous plasma at a vendor and then reworked through an internal waterjet rework process may not have sufficient adhesion strength. The waterjet rework process for porous plasma coating has not been validated for products that were coated at a vendor, creating a risk that the coating may not properly adhere to the implant.
Affected units were distributed worldwide, including throughout the US, Canada, Ecuador, and the Netherlands. A total of 11 units are in scope under Lot Number 396250.
Physicians and patients who have received this implant should contact Biomet for guidance. Healthcare providers should check their inventory for the affected lot number and discontinue use if units are identified.
The recalled product
- Product
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
- Manufacturer
- Biomet, Inc.
- Hazard
- adhesion-failure
- coating-defect
- implant-failure-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 396250 UDI: (01)00880304462663(17)281121(10)396250
Distribution
Distributed nationwide across the United States.
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