Devices

Device Recall Pinnacle Cancellous Screw

Model / Serial
Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
Product Description
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
DePuy Orthopaedics, Inc.
1 Event
- Recall of Device Recall Pinnacle Cancellous Screw

Manufacturer

DePuy Orthopaedics, Inc.

Manufacturer Address
DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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