Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used t...
FDA Recall #Z-1146-2015 — Class II — November 30, 2012
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.
Reason for Recall
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Recalling Firm
Biomet Spine, LLC — Broomfield, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1999
Distribution
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.
Code Information
LOT Numbers: L561968 and L570545 Product Code: 77031600
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated