Recall Z-1146-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Biomet Spine, LLC
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),
| Date | Feb 24, 2015 (initiated Nov 30, 2012) |
| Status | Terminated |
| Reason | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification |
| Root cause | Process control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122145 | LANX SPINAL FIXATION SYSTEM Lanx, Inc., Aug 17, 2012 |