Recall Z-1605-2015— BioHorizons Implant Systems Inc

Name: FDA recall Z-1605-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Class II · Terminated

Class II FDA medical device recall by BioHorizons Implant Systems Inc, initiated 2015-04-16, terminated 2015-08-07. It names one FDA 510(k) clearance: K071638. Product: Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement. Reason: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium..

Recalling firm: BioHorizons Implant Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Terminated: 2015-08-07
Firm location: Hoover, AL, United States

510(k) clearances named in this recall

1 on FDA's record

K071638 — BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEMBioHorizons Implant Systems, Inc.·cleared 2007-10-10

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

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

Reason for recall

BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

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