Recall Z-2751-2016— Biomet Microfixation, LLC

Name: FDA recall Z-2751-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-13

Class II · Terminated

Class II FDA medical device recall by Biomet Microfixation, LLC, initiated 2016-06-13, terminated 2019-08-21. It names one FDA 510(k) clearance: K924935. 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.. Reason: Potential sterility deficiency..

Recalling firm: Biomet Microfixation, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-06-13
Terminated: 2019-08-21
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K924935 — HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANTPolyclinic Medical Center·cleared 1993-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.