Recall Z-0391-2016— BioHorizons Implant Systems Inc

Name: FDA recall Z-0391-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-30

Class II · Terminated

Class II FDA medical device recall by BioHorizons Implant Systems Inc, initiated 2015-10-30, terminated 2016-02-04. It names one FDA 510(k) clearance: K073268. Product: RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant. Reason: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging..

Recalling firm: BioHorizons Implant Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-30
Terminated: 2016-02-04
Firm location: Hoover, AL, United States

510(k) clearances named in this recall

1 on FDA's record

K073268 — BIOHORIZONS INTERNAL IMPLANT SYSTEMBioHorizons Implant Systems, Inc.·cleared 2008-02-08

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

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

Reason for recall

An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

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