Z-0962-2013Class II

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal...

Name: Z-0962-2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal...
Creator: DePuy Spine, Inc.
Published: 2013-01-15
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2013-01-15 / Terminated / root cause: manufacturing process

FDA source

DePuy Spine, Inc. began a recall of DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of... on 2013-01-15. FDA classified it as Class II and gives the reason as "Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0962-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-15
Posted: 2013-03-18
Terminated: 2014-06-30
Recalling firm: DePuy Spine, Inc.
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.
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes Spine issued notification letter dated 1/11/13 issued via UPS Next Day Air Saver on 17 January 2013. Accounts requested to review inventory, quarantine any products listed in this recall notice and to complete and return the enclosed Business Reply Form. Contact the firm at 508-977-6606 for questions relating to this notice.
Quantity in commerce: 7773
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0962-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0960-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18
Z-0961-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18
Z-0962-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18
Z-0963-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-18

Product code NDN

K060300Class IIConfidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. / cleared 2006-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)