The Recall Desk
SevereFDA (Devices)·Z-0713-2013·Announced 2013-01-30

DePuy Spine VIPER Polyaxial Screws Recalled for Potential Component 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 agency classified this as a Class II recall involving a structural defect in a spinal implant, which aligns with the rubric criteria for a Severe rating.

Plain-English summary

DePuy Spine, Inc. is recalling VIPER Polyaxial Screws, specifically the 5.5 10x100mm model (Product Code: 1867-15-199). The recall involves 10 units distributed nationwide in the United States and in Australia.

The recall is due to a potential mechanical defect where the screw shank may separate from the polyaxial head. This risk is associated with high-torque circumstances, such as when inserting polyaxial screws 8x 80 and larger into the ilium.

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

The recalled product

Product
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
10

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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