Recall Z-2102-2011
DePuy Spine, Inc. · initiated March 22, 2011
Product
Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 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.
Codes / lots: Lot Code: HLPB4G
Reason for recall
Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-2102-2011
- Initiated
- March 22, 2011
- Posted by FDA
- April 27, 2011
- Terminated
- February 20, 2013
- Product code
- OCJ – Spinal Channeling Instrument, Vertebroplasty
- Quantity
- 215 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.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2103-2011 | Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The…Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle | 03/22/2011Terminated |