Recall Z-0706-2013
DePuy Spine, Inc. · initiated November 7, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
Codes / lots: All lots
Reason for recall
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
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-0706-2013
- Initiated
- November 7, 2012
- Posted by FDA
- January 24, 2013
- Terminated
- December 24, 2013
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 36 units
- 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.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0705-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0707-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0708-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0709-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0710-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0711-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0712-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long… | 11/07/2012Terminated |
| Z-0713-2013 Class II | DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant…Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long… | 11/07/2012Terminated |