Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion
Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.
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 involving a structural defect in orthopedic implant coating adhesion. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
Biomet, Inc. is recalling 12 units of the Comprehensive Shoulder System Primary Shoulder Stem (Item Number 113614, Lot Number 439470) due to a manufacturing defect affecting the porous plasma coating.
The recalled products underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the coating may not have sufficient adhesion strength. The issue affects all products that were porous plasma coated or recoated at a vendor and then reworked through Biomet's internal waterjet rework process. Biomet determined that the waterjet rework process for porous plasma coating is not validated for products that were initially coated by a vendor.
The affected implant components were distributed worldwide, including in the United States, Canada, Ecuador, and the Netherlands.
The recalled product
- Product
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
- 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: 439470 UDI: (01)00880304554153(17) 290803(10)439470
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