Recall Z-2132-2013— DePuy Spine, Inc.

Name: FDA recall Z-2132-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-17

Class II · Terminated

Class II FDA medical device recall by DePuy Spine, Inc., initiated 2013-04-17, terminated 2014-08-13. It names one FDA 510(k) clearance: K060300. Product: CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.. Reason: During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement..

Recalling firm: DePuy Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Terminated: 2014-08-13
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K060300 — CONFIDENCE HIGH VISCOSITY BONE CEMENTDisc-O-Tech Medical Technologies, Ltd.·cleared 2006-06-21

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

CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Reason for recall

During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

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