Home / Recalls / DePuy Orthopaedics, Inc. / Z-0569-2013

Z-0569-2013 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-0569-2013 was initiated by DePuy Orthopaedics, Inc. on Nov 28, 2012 and is designated Class II. 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… The recall status is terminated (terminated Mar 20, 2013). Affected quantity: 118 units.

Recall Details

Product Type
Devices
Report Date
Dec 26, 2012
Initiation Date
Nov 28, 2012
Termination Date
Mar 20, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
118 units

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.

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.

Distribution Pattern

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

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0569-2013
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources