Recall Z-2133-2013
DePuy Spine, Inc. · initiated April 17, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / 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
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.
FDA-determined cause: Process control
Action taken
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 DePuy7862@stericycle.com and to return the product with the enclosed UPS label to Stericycle. For questions regarding this recall call 508-977-6606.
Details
- Recall number
- Z-2133-2013
- Initiated
- April 17, 2013
- Posted by FDA
- September 3, 2013
- Terminated
- August 13, 2014
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Quantity
- 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…
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2132-2013 Class II | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal…During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body… | 04/17/2013Terminated |
| Z-2134-2013 Class II | CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal…During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body… | 04/17/2013Terminated |