Recalls / —

—#30986

Product

Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 65 mm; Product 903005065.

FDA product code

HSB — Rod, Fixation, Intramedullary And Accessories

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K010780

Affected lot / code info

All.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Depuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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.

Timeline

Recall initiated

2003-12-11

Posted by FDA

2004-01-31

Terminated

2004-04-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #30986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.