The Recall Desk
SevereFDA (Devices)·Z-0706-2013·Announced 2013-01-30

DePuy Spine Recalls VIPER Polyaxial Screws Due to Potential Separation

DePuy Spine is recalling 36 units of 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 during surgery, meeting the criteria for a Severe rating.

Plain-English summary

DePuy Spine, Inc. is recalling 36 units of VIPER Polyaxial Screws (Product Code: 1867-15-880). The recall involves 8x80mm and larger polyaxial screws used as spinal implant components.

The recall was initiated because the screw shank has the potential to separate from the polyaxial head when inserted in the Ilium under high-torque circumstances. This defect may cause the screw to disassociate during the insertion process.

The affected units were distributed worldwide, including nationwide in the United States (specifically in AZ, CA, FL, HI, IL, MD, MI, MO, NC, TN, and TX) and in Australia. All lots of the specified product code are included in this recall. Healthcare providers and patients should contact DePuy Spine for further instructions regarding the removal or replacement of these devices.

The recalled product

Product
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
Manufacturer
DePuy Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
36

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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