Biomet Spine, LLC recalls Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titaniu

Recalled March 4, 2015 · FDA recall Z-1146-2015 · Biomet Spine

Hazard

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

Units

1999

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Biomet Spine, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →