DePuy Orthopaedics, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0569-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 28, 2012

Date Posted: December 26, 2012

Recall Number: Z-0569-2013

Event ID: 62764

Reason for Recall:

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.

Status: Terminated

Product Quantity: 118 units

Code Information:

Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated