Biomet Microfixation, LLC: Medical Device Recall in 2016 - (Recall #: Z-2751-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 13, 2016

Date Posted: September 14, 2016

Recall Number: Z-2751-2016

Event ID: 74798

Reason for Recall:

Potential sterility deficiency.

Status: Terminated

Product Quantity: 54 units

Code Information:

Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated