Z-2103-2011

Confidence Introducer Needle Side Hole 13G x 4-Inch

Name: Z-2103-2011 Confidence Introducer Needle Side Hole 13G x 4-Inch
Creator: DePuy Spine, Inc.
Published: 2011-03-22
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2011-03-22 / Terminated / root cause: packaging

FDA source

DePuy Spine, Inc. began a recall of Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The Confidence Needles are supplied sterile. They are used to place bone cement... on 2011-03-22. The reason FDA records is "Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2103-2011
Status: Terminated
Initiated: 2011-03-22
Posted: 2011-04-27
Terminated: 2013-02-20
Recalling firm: DePuy Spine, Inc.
Product: Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.
Product code: OCJ Spinal Channeling Instrument, Vertebroplasty
Reason for recall: Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, DePuy Spine, sent an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated March 22, 2011 to its consignees/customers ( hospital sites and domestic sales distributors). A product reconciliation form was provided to assist in the retrieval of affected product. The letter described the product, problem and actions to be taken. The customers were instructed to return any needles that they may have to their local Distributor for DePuy Spine products and complete and return the Product Reconciliation Form via fax to 508-828-3762; call Customer Service at 877-379-4871 to receive a return goods authorization number and/or mail the form with the return product to DePuy Spine Inc., 50 Scotland Boulevard, Bridgewater, MA 02324, Attn: CONFIDENCE NEEDLE RECALL COORDINATOR, RGA #. If you have any questions or concerns with regard to this notice, please contact the DePuy Spine Regulatory Compliance Department at 508-828-2790.
Quantity in commerce: 67 units
Distribution: Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.
Product codes and lots: Lot Code: HLPB4F

Product code OCJ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)