Recall Z-0569-2013 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DePuy Orthopaedics, Inc.
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to
| Date | Dec 19, 2012 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw. |
| Root cause | Labeling Change Control |
| Action | The firm, DePuy Orthopedics, Inc., sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" dated July 2012 to its customers via email and mail. The notice described the product, problem and actions to be taken. The customers were instructed to determine whether they would like to retain and use the product or return affected product to DePuy in Warsaw, IN, and to complete and return the Reconciliation forms to your DePuy Sales Representative or by fax to: 574-371-4939. DePuy sales representatives are expected to aid customers in returning of recalled products. For questions about recall |
| Quantity | 118 units |
| Distribution | Nationwide distribution: USA states of: GA, MA, MN, SC and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000306 | PINNACLE ACETABULAR SYSTEM DePuy Orthopaedics, Inc., Mar 23, 2000 |