DePuy Spine, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2133-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 17, 2013

Date Posted: September 11, 2013

Recall Number: Z-2133-2013

Event ID: 64937

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.

Status: Terminated

Product Quantity: 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated