DePuy Spine, Inc.: 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.

Recall number

Z-2103-2011

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.

Status

Terminated

Initiated

2011-03-22

Posted

2011-04-27

Terminated

2013-02-20

Reason

Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle

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

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.

Lot, serial or model codes

Lot Code: HLPB4F

510(k) numbers

not on file

PMA numbers

not on file

Product code

OCJ

Firm FEI

1526439

Firm city

Raynham

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy