Reported Jan 30, 2013 · Terminated
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
DePuy Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Spine, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199
Is this the product you have?
- DePuy Spine VIPER POLY SCREW 5.5 10
- X 80MM Tl Product Code1867-15-180 Spinal Implant Component
- Lot codes and dates
- All lots
- Amount recalled
- 6 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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