FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
- Recall number
- Z-0710-2013
- Recalling firm
- DePuy Spine, Inc.
- Product
- DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
- Status
- Terminated
- Initiated
- 2012-11-07
- Posted
- 2013-01-24
- Terminated
- 2013-12-24
- Reason
- 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
- 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 lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
- Quantity
- 23 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K101993"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28