Z-0712-2013Class II

DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl

Name: Z-0712-2013 DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
Creator: DePuy Spine, Inc.
Published: 2012-11-07
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2012-11-07 / Terminated

FDA source

DePuy Spine, Inc. began a recall of DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component on 2012-11-07. FDA classified it as Class II and gives the reason as "Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0712-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-07
Posted: 2013-01-24
Terminated: 2013-12-24
Recalling firm: DePuy Spine, Inc.
Product: DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
FDA root cause: Component change control
Action: DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to [email protected]. For questions call Linda Regan @508-977-6606.
Quantity in commerce: 6 units
Distribution: Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0712-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0705-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0706-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0707-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0708-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0709-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0710-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0711-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0712-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23
Z-0713-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-23

Product code NKB

K101993Class IIViper System, Expedium SystemDepuy Spine, Inc. / cleared 2010-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)