Recall Z-2751-2016 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Biomet Microfixation, LLC
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.
| Date | Jun 13, 2016 |
| Status | Terminated |
| Reason | Potential sterility deficiency. |
| Root cause | Packaging |
| Action | Zimmer Biomet Customers were sent an Urgent Product Recall letter dated June 13, 2016, via via FedEx mail. The letter notified customers of a recall of Hard Tissue Replacement Polymer Implants due to voids in sterile packaging. The firm instructed customers to locate and discontinue use of the implants, complete the Fax Response form and fax it to 904-741-9425, send back any quarantined product using the FedEx labels provided along with the recall notification, and to notify facilities where the implant was further distributed by forwarding them a copy of the provided notice. The firm instruct |
| Quantity | 54 units |
| Distribution | Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT Polyclinic Medical Center, Sep 2, 1993 |