Recall Z-0561-2013— BioHorizons Implant Systems Inc

Name: FDA recall Z-0561-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-19

Class II · Terminated

Class II FDA medical device recall by BioHorizons Implant Systems Inc, initiated 2012-11-19, terminated 2013-09-24. It names one FDA 510(k) clearance: K993493. Product: AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.. Reason: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use..

Recalling firm: BioHorizons Implant Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-19
Terminated: 2013-09-24
Firm location: Birmingham, AL, United States

510(k) clearances named in this recall

1 on FDA's record

K993493 — THE AUTOTAC SYSTEMBioHorizons Implant Systems, Inc.·cleared 2000-01-07

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

AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Reason for recall

The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

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