FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 926213340.
- Recall number
- Z-0416-04
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 926213340.
- Status
- Terminated
- Initiated
- 2003-12-11
- Posted
- 2004-01-31
- Terminated
- 2004-04-15
- Reason
- The lag screw may migrate to the femoral head or into the abdominal cavity.
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- All.
- 510(k) numbers
- ["K013563"]
- PMA numbers
- not on file
- Product code
- HSB
- 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