Comprehensive Shoulder System Mini Humeral Stem Recalled for Coating Adhesion Defect
Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.
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 a Class II medical device recall involving a surgical implant with a structural coating defect that could lead to implant failure. No injuries or illnesses have been reported, but the product poses an inherent risk to patient safety. Per the rubric, risk-of-harm products where injury has not yet been reported score at the High level.
Plain-English summary
Biomet, Inc. is recalling 11 units of the Comprehensive Shoulder System Mini Humeral Stem (Item Number 113631, Lot 821860) worldwide. This product is a surgical implant component used in shoulder replacement procedures.
The recall is due to a manufacturing defect in the porous plasma spray coating. An incorrect rework operation was performed on parts originally coated by an external vendor, using an internal waterjet rework process that has not been validated for vendor-coated products. Internal testing found that the coating may not have sufficient adhesion strength, which could lead to implant failure.
The affected lot was distributed worldwide, including to the United States, Canada, Ecuador, and the Netherlands. Only 11 units are involved in this recall.
If you have received this implant, contact your surgeon or healthcare provider for guidance. Biomet and healthcare facilities are coordinating with the FDA on this recall.
The recalled product
- Product
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
- Manufacturer
- Biomet, Inc.
- Hazard
- adhesion-defect
- implant-failure
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: 821860 UDI: (01)00880304462687(17) 290522(10)821860
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03