BioHorizons Implant Systems

5 recalls •

🏥 Medical Devices

• Categories: Implants & Prosthetics, Infusion Pumps, Other Medical Devices

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

Class I - Dangerous

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

Oct 30, 2015 Implants & Prosthetics View Details →

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

Class I - Dangerous

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.

Apr 16, 2015 Implants & Prosthetics Nationwide View Details →

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

Class I - Dangerous

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

Dec 10, 2013 Implants & Prosthetics Nationwide View Details →

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

Class I - Dangerous

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

Nov 19, 2012 Infusion Pumps Nationwide View Details →

Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.

Class I - Dangerous

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

Nov 19, 2012 Other Medical Devices Nationwide View Details →