Home / Recalls / Biomet Spine, LLC / Z-1146-2015

Z-1146-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
March 4, 2015
Initiation Date
November 30, 2012
Termination Date
May 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1999

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

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.

Code Information

LOT Numbers: L561968 and L570545 Product Code: 77031600

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