Z-2751-2016 Class II Terminated
FDA device recall Z-2751-2016 was initiated by Biomet Microfixation, LLC on June 13, 2016 and is designated Class II. Reason for recall: Potential sterility deficiency. The recall status is terminated (terminated August 21, 2019). Affected quantity: 54 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- June 13, 2016
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 units
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.
Reason for Recall
Potential sterility deficiency.
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.
Code Information
Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016