Recall Z-0962-2013— DePuy Spine, Inc.

Name: FDA recall Z-0962-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-15

Class II · Terminated

Class II FDA medical device recall by DePuy Spine, Inc., initiated 2013-01-15, terminated 2014-06-30. It names one FDA 510(k) clearance: K060300. Product: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.. Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck.

Recalling firm: DePuy Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-15
Terminated: 2014-06-30
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

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

Reason for recall

Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

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