Z-0569-2013Class II

Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside...

Name: Z-0569-2013 Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-11-28
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-11-28 / Terminated / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This... on 2012-11-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0569-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2012-12-19
Terminated: 2013-03-20
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 118 units
Distribution: Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
Product codes and lots: Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0569-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0569-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code LPH

K000306Class IIPinnacle Acetabular SystemDePuy Orthopaedics, Inc. / cleared 2000-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)