Biomet Shoulder Implant Stem Recalled for Coating Adhesion Defect
Biomet recalls 9 Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion defects. An incorrect rework process may have compromised the porous plasma coating adhesion 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: FDA Class II recall of an orthopedic implant with a confirmed defect in coating adhesion identified through internal testing. While no injuries or hospitalizations have been reported, the product represents a risk-of-harm scenario (potential implant failure) where injury has not yet been reported, justifying a High severity rating.
Plain-English summary
Biomet, Inc. is recalling 9 units of the Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long (Item Number 113633, Lot 994800). Affected units have been distributed worldwide to the United States, Canada, Ecuador, and the Netherlands.
The recall was initiated after internal testing revealed that certain units underwent an incorrect rework operation of the porous plasma sprayed coating. Affected units may not have sufficient adhesion strength of the coating. The defect affects all lots that were porous plasma coated or recoated at an external vendor and then reworked through Biomet's internal waterjet rework process. This waterjet rework process has not been validated for products originally coated by a vendor.
The potential coating defect creates a risk of adhesion failure in this surgical implant. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
- Manufacturer
- Biomet, Inc.
- Hazard
- coating-adhesion-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: 994800 UDI:(01)00880304462632(17)290816(10)994800
Distribution
Distributed nationwide across the United States.
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