Biomet Microfixation, LLC recalls Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are…

Recall date

June 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2751-2016

FDA classification

Class II

Brand / firm

Biomet Microfixation, LLC

Sold / distributed

Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.

Why it was recalled

Potential sterility deficiency.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.