The Recall Desk
SevereFDA (Devices)·Z-0707-2013·Announced 2013-01-30

DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

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 that could lead to significant injury or device failure.

Plain-English summary

DePuy Spine, Inc. is recalling VIPER Polyaxial Screws, specifically the 8x100mm size and other large diameter long screws (8x80mm and larger). The recall is due to a potential defect where the screw shank may separate from the polyaxial head when inserted in the Ilium or during high-torque circumstances.

The affected product is a spinal implant component. The recall covers all lots of the product. Distribution was worldwide, including nationwide distribution in the United States and in Australia.

Healthcare providers and patients should contact DePuy Spine, Inc. for further information regarding the recall and potential replacement or removal of the device.

The recalled product

Product
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard

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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