Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-1146-2015)

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:

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Product Classification:

Class II

Date Initiated: November 30, 2012

Date Posted: March 4, 2015

Recall Number: Z-1146-2015

Event ID: 70383

Reason for Recall:

Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

Status: Terminated

Product Quantity: 1999

Code Information:

LOT Numbers: L561968 and L570545 Product Code: 77031600

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated