Recall

Class II — DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalling firm	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Registered facility	DePuy Mitek, Inc. (the firm's only registered facility)
Classification	Class II
Status	Terminated
Reason	Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Product	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.
Quantity	530 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.
Initiated	2012-05-04
Classified	2012-07-03
Terminated	2016-08-04
Recall number	Z-1939-2012
Initiation	Voluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — DePuy Mitek, Inc., a Johnson & Johnson Co. (Z-1939-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/61874/

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