CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percu

FDA device recall Z-2134-2013 · posted 2013-09-03 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

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.

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.

Root cause

Process control

Status

Terminated

Product code

NDN

Quantity affected

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

Date initiated

2013-04-17

Date posted

2013-09-03

Date terminated

2014-08-13

Location

Raynham, MA

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