DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl recallZ-0709-2013 · DePuy Spine, Inc. · initiated Nov 7, 2012

Why it was recalled

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 category: Component change control

What the company is doing

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.

Recall details

Recall number

Z-0709-2013

Recall class

Class II

Status

Terminated

Initiated by the company

Nov 7, 2012

Posted by the FDA

Jan 24, 2013

Recalling firm

DePuy Spine, Inc.

Quantity

34 uits

Product code

NKB

FDA submissions

K101993

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 description

DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.

Other devices under the same FDA submission

22 devices cleared under K101993 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• EXPEDIUM 179712880

  Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  8 reports
• EXPEDIUM 179712980

  Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation
  6 reports
• VIPER 186715850

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  6 reports
• EXPEDIUM 179712850

  Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation
  5 reports
• EXPEDIUM 179712990

  Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
  4 reports
• EXPEDIUM 179712199

  Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• EXPEDIUM 179712840

  Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation
  2 reports
• EXPEDIUM 179712855

  Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• EXPEDIUM 179712870

  Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease
  2 reports
• EXPEDIUM 179712875

  Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• EXPEDIUM 179712960

  Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
  2 reports
• EXPEDIUM 179712280

  Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 63665).

• Z-0705-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.
• Z-0706-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
• Z-0707-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
• Z-0708-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.
• Z-0710-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
• Z-0712-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
• Z-0713-2013 · Terminated
  DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.