Recall Z-1058-2014— BioHorizons Implant Systems Inc

Name: FDA recall Z-1058-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Class II · Terminated

Class II FDA medical device recall by BioHorizons Implant Systems Inc, initiated 2013-12-10, terminated 2014-03-28. It names one FDA 510(k) clearance: K030463. Product: External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental. Reason: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length..

Recalling firm: BioHorizons Implant Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Terminated: 2014-03-28
Firm location: Birmingham, AL, United States

510(k) clearances named in this recall

1 on FDA's record

K030463 — MODIFICATION TO THE MAESTRO SYSTEMBioHorizons Implant Systems, Inc.·cleared 2003-02-26

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

External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental

Reason for recall

The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.

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