BioHorizons Implant Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1605-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 16, 2015

Date Posted: May 20, 2015

Recall Number: Z-1605-2015

Event ID: 71125

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.

Status: Terminated

Product Quantity: 48 units

Code Information:

Lot Number 1501968

Distribution Pattern:

US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.

Voluntary or Mandated:

Voluntary: Firm initiated