—#111672

Product

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 the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K000306
Affected lot / code info: Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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 information provided, please contact the Manager, Post-Market Surveillance, 574-372-7333 (M-F; 8 am - 5 pm EDT.)

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide distribution: USA states of: GA, MA, MN, SC and VA.

Timeline

Recall initiated: 2012-11-28
Posted by FDA: 2012-12-19
Terminated: 2013-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.