Recall Z-0712-2013— DePuy Spine, Inc.

Name: FDA recall Z-0712-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-07

Class II · Terminated

Class II FDA medical device recall by DePuy Spine, Inc., initiated 2012-11-07, terminated 2013-12-24. It names one FDA 510(k) clearance: K101993. Product: DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.. 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.

Recalling firm: DePuy Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-11-07
Terminated: 2013-12-24
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K101993 — VIPER SYSTEM, EXPEDIUM SYSTEMDepuy Spine, Inc.·cleared 2010-12-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.