Z-0394-04

Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 925209400

Name: Z-0394-04 Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 925209400
Creator: Depuy Orthopaedics, Inc.
Published: 2003-12-11
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2003-12-11 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 925209400 on 2003-12-11. The reason FDA records is "The lag screw may migrate to the femoral head or into the abdominal cavity". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0394-04
Status: Terminated
Initiated: 2003-12-11
Posted: 2004-01-31
Terminated: 2004-04-15
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 925209400.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The lag screw may migrate to the femoral head or into the abdominal cavity.
FDA root cause: Other
Action: Recall letters dated 12/15/03 were issued to receiving hospitals. Hospitals were instructed to cease implantation, quarantine stocks, and to notify implanting physicians to monitor their patients.
Distribution: United States, Austria, Australia, Belgium, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Portugal, Repulic of Korea, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, United Arab Republic and the United Kingdom.
Product codes and lots: All.

Product code HSB

K013563Class IILong Trochanteric Nail SystemDePuy Orthopaedics, Inc. / cleared 2001-12-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)