Recall Z-0709-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
DePuy Spine, Inc.
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
| Date | Jan 24, 2013 (initiated Nov 7, 2012) |
| Status | Terminated |
| Reason | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Root cause | Component change control |
| Action | DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606. |
| Quantity | 34 uits |
| Distribution | Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM Depuy Spine, Inc., Dec 7, 2010 |