DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0706-2013.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0706-2013.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Depuy Spine, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0706-2013.
DePuy Spine, Inc.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Depuy Spine, Inc. Recall FAQ
Depuy Spine, Inc. is the subject of a medical implants safety report: DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.. The notice was published on November 7, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 36 units are potentially affected.