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.
This recall has been terminated (originally issued February 24, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- November 30, 2012
- Posted
- February 24, 2015
- Terminated
- May 22, 2015
- Recall Number
- Z-1146-2015
- Quantity
- 1999
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
LOT Numbers: L561968 and L570545 Product Code: 77031600
Root Cause
Process control
Action Taken
Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.
More recalls by Biomet Spine Llc.
10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230.
Pr...
Feb 12, 2016
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Ante...
Nov 3, 2015
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 an...
Sep 10, 2015