The Recall Desk
SevereFDA (Devices)·Z-0709-2013·Announced 2013-01-30

DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

DePuy Spine is recalling VIPER Polyaxial Screws 8x80mm and larger 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 during surgery.

Plain-English summary

DePuy Spine, Inc. is recalling VIPER Polyaxial Screws, specifically the 5.5 9 x 80mm model (Product Code: 1867-15-980). The recall involves 34 units distributed nationwide in the US and in Australia.

The recall is due to a risk that polyaxial screws 8x80mm and larger may disassociate when inserted into the Ilium. In high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

Healthcare providers and patients who have received these specific spinal implant components should contact DePuy Spine, Inc. for further instructions on management and replacement.

The recalled product

Product
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
34

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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