FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: 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.
- Recall number
- Z-0569-2013
- Recalling firm
- DePuy Orthopaedics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-28
- Posted
- 2012-12-19
- Terminated
- 2013-03-20
- Reason
- 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
- Labeling Change Control
- Action
- 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.)
- Quantity
- 118 units
- Distribution
- Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
- Lot, serial or model codes
- Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
- 510(k) numbers
- ["K000306"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28