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

Recalled September 14, 2016 · FDA recall Z-2751-2016 · Biomet Microfixation

Hazard

Potential sterility deficiency. · FDA Class II

Units

54 units

Sold at

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

Description

Potential sterility deficiency.

Product

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.

Manufacturer(s)

Biomet Microfixation, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →