Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hard Tissue Replacement (HTR) Implant Recalled by Biomet Microfixation, LLC Due to Potential sterility deficiency.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomet Microfixation, LLC directly.
Affected Products
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Quantity: 54 units
Why Was This Recalled?
Potential sterility deficiency.
Where Was This Sold?
This product was distributed to 8 states: AZ, CA, FL, MO, NH, PA, TX, VA
About Biomet Microfixation, LLC
Biomet Microfixation, LLC has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report