Z-2133-2013Class II

Confidence Spinal Cement System 11Cc Plus Kit

Name: Z-2133-2013 Confidence Spinal Cement System 11Cc Plus Kit
Creator: DePuy Spine, Inc.
Published: 2013-04-17
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2013-04-17 / Terminated / root cause: manufacturing process

FDA source

DePuy Spine, Inc. began a recall of CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of... on 2013-04-17. FDA classified it as Class II and gives the reason as "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". 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-2133-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Posted: 2013-09-03
Terminated: 2014-08-13
Recalling firm: DePuy Spine, Inc.
Product: CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 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
Product code: NDN Cement, Bone, Vertebroplasty
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePut Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated April 15, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the con signee. Consignees were instructed to review their inventory and quarantine for return any products listed in the recall notice., complete the enclosed Business Reply Form, indicating level of inventory of the affected product and return the form to Depuy via fax to 888-943-4897or email to [email protected] and to return the product with the enclosed UPS label to Stericycle. For questions regarding this recall call 508-977-6606.
Quantity in commerce: 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)
Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV, WY; Worldwide: Algeria, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Latvia, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UAE, and UK
Product codes and lots: HPBB0K, HPBB3C,HPCB7J, HPDBD6, HPBB0L,HPBB3D,HPCB7W,HPDBF0, HPBB0M,HPBB3F,HPDBBC,HPDBG4, HPBB0N,HPBBWH,HPDBBD,HPDBGB, HPBB0P,HPBBWJ,HPDBBK,HPDBGC,HPBB0T,HPBBWL,HPDBBL,HPDBGJ, HPBB19,HPBBZ8,HPDBBY,HPDBGM,HPBB27,HPBBZD,HPDBCD,HPDBGN, HPBB29,HPBBZN,HPDBCF, HPDBGY,HPBB2B,HPCB7B,HPDBD0,HPBB2C, HPCB7C,HPDBD3,HPBB2G,HPCB7H,HPDBD4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2132-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2133-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03
Z-2134-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-03

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)