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Terminated

Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 13 mm; Product 903213225.

FDA Recall Z-0434-04 · Posted 2004-01-31

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2003-12-11
Date Terminated2004-04-15

Reason for Recall

The lag screw may migrate to the femoral head or into the abdominal cavity.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010780TROCHANTERIC NAILDePuy Orthopaedics, Inc. · 2001-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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