DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
FDA device recall Z-0713-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 10 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.
- Date initiated
- 2012-11-07
- Date posted
- 2013-01-24
- Date terminated
- 2013-12-24
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIPER SYSTEM, EXPEDIUM SYSTEM (K101993) | Depuy Spine, Inc. | 2010-12-07 |