Z-1940-2012Class II

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

Name: Z-1940-2012 Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-05-04
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-05-04 / Terminated / root cause: labeling and UDI

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle... on 2012-05-04. FDA classified it as Class II and gives the reason as "Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1940-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-04
Posted: 2012-07-03
Terminated: 2016-08-04
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. 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 code: OAR Injector, Vertebroplasty (Does Not Contain Cement)
Reason for recall: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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 .
Quantity in commerce: 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, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1937-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03
Z-1938-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03
Z-1939-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03
Z-1940-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03

Product code OAR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)