DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Reported: January 30, 2013 Initiated: November 7, 2012 #Z-0712-2013
Product Description
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
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
Details
- Recalling Firm
- DePuy Spine, Inc.
- Units Affected
- 6 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.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.. Recalled by DePuy Spine, Inc.. Units affected: 6 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2013. Severity: Moderate. Recall number: Z-0712-2013.
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