DePuy Mitek, Inc., a Johnson & Johnson Co.: Medical Device Recall in 2012 - (Recall #: Z-1939-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.

Product Classification:

Class II

Date Initiated: May 4, 2012

Date Posted: July 11, 2012

Recall Number: Z-1939-2012

Event ID: 61874

Reason for Recall:

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

Status: Terminated

Product Quantity: 530 units

Code Information:

All lots

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated