Biomet Shoulder Implant Stem Coating Adhesion Defect Recall
Biomet is recalling shoulder implant stems due to improper rework of porous plasma coating, which may lack sufficient adhesion strength. Affected units may fail if the coating detaches.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall for a structural defect in orthopedic implant coating with potential for failure. No illnesses or injuries have been reported. The hazard represents risk-of-harm if coating adhesion fails, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling the Comprehensive Shoulder System Mini Humeral Stem (Item Number 113632) due to a manufacturing defect. Affected units underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing found that the coating may not have sufficient adhesion strength.
The recall applies to all lots that were porous plasma coated or recoated at a vendor and then processed through Biomet's internal waterjet rework procedure. The waterjet rework process has not been validated for products coated by external vendors. Affected units are identified by Lot Number 327160 (UDI: 01008803044497491729081910327160).
The implant stems have been distributed worldwide, including throughout the United States and to Canada, Ecuador, and the Netherlands. Patients who have received this implant should consult with their healthcare provider about the recall and any necessary follow-up care.
The recalled product
- Product
- Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632
- Manufacturer
- Biomet, Inc.
- Affected units
- 12
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: 327160 UDI: (01)00880304449749(17)290819(10)327160
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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