Recall Z-2103-2011 ยท OCJ Spinal Channeling Instrument, Vertebroplasty
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 whi
| Date | Apr 27, 2011 (initiated Mar 22, 2011) |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.