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DePuy Orthopaedics, Inc. recalls Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an unco
Recalled December 26, 2012 · FDA recall Z-0569-2013 · DePuy Orthopaedics
Hazard
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. · FDA Class II
Units
118 units
Sold at
Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
Description
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.
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.
Manufacturer(s)
DePuy Orthopaedics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →