Home / Recalls / DePuy Spine, Inc. / Z-2134-2013

Z-2134-2013 Class II Terminated

Recalled by DePuy Spine, Inc. — Raynham, MA

FDA device recall Z-2134-2013 was initiated by DePuy Spine, Inc. on April 17, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 13, 2014). Affected quantity: 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways).

Recall Details

Product Type: Devices
Report Date: September 11, 2013
Initiation Date: April 17, 2013
Termination Date: August 13, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3896 units (Overall quantity distributed appears greater than quantities manufactured due to the distribution pathways)

Product Description

CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 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.

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

Code Information

HPBB0B, HPBBWM, HPCB75, HPCCBN, HPBB0R, HPBBWP, HPCB7D, HPDBBV, HPBB28, HPBBZ7, HPCB7F, HPDBCG, HPBB2D, HPBBZF, HPCB7T, HPDBD1, HPBB2F, HPBCKH, HPCB7V, HPDBD5, HPBB4R, HPBDL9, HPCB8G, HPDBF9, HPBBV1, HPCB67, HPCBLC, HPDBGH, HPBBWG, HPCB68, HPCBM1, HPDBGK, HPBBWK, HPCB74, HPCCBM, HPDBGL

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