The Recall Desk
SevereFDA (Devices)·Z-0708-2013·Announced 2013-01-30

DePuy Spine VIPER Polyaxial Screw Recall for Potential Disassociation

DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a spinal implant where the screw shank may separate, posing a significant risk of injury.

Plain-English summary

DePuy Spine, Inc. is recalling 24 units of VIPER Polyaxial Screws (Product Code: 1867-15-970). The recall covers all lots of the 5.5 x 9 x 70mm Tl spinal implant component.

The recall was initiated because polyaxial screws 8x 80 and larger may disassociate when inserted into the Ilium. Additionally, VIPER large diameter long screws in high-torque circumstances have the potential for the screw shank to separate from the polyaxial head.

The affected products were distributed worldwide, including nationwide in the United States (specifically AZ, CA, FL, HI, IL, MD, MI, MO, NC, TN, and TX) and in Australia. Healthcare professionals should contact DePuy Spine, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 9 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · DePuy Spine, Inc.

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Same hazard · structural failure

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