Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 28390

FDA device recall Z-1940-2012 · posted 2012-07-03 · Terminated

Recall details

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Reason for recall

Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles

Action taken

Depuy Spine sent a "CORRECTION NOTICE" to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Notification Form was attached for customers to complete and return via fax to 508-828-3070. For questions about Confidence Needles, please contact your local DePuy Spine Sales Representative. If you need assistance in locating your local Sales Representative please contact JJHCS CIS @ 1 -800-255 -2500 .

Root cause

Labeling design

Status

Terminated

Product code

OAR

Quantity affected

6979 units

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russia

Date initiated

2012-05-04

Date posted

2012-07-03

Date terminated

2016-08-04

Location

Raynham, MA