Recalls / —

—#34305

Product

Guardian Distal Femur Axial Pin

FDA product code

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K013035

Affected lot / code info

Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074

Why it was recalled

Potential for self -locking axial pin to dislodge and 'back out'.

Root cause (FDA determination)

Other

Action the firm took

The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.

Recalling firm

Firm

Wright Medical Technology Inc

Address

5677 Airline Road P.O. Box 100, Arlington, Tennessee 38002-0100

Distribution

Distribution pattern

Nationwide. Ontario, and Taiwan, ROC

Timeline

Recall initiated

2004-07-14

Posted by FDA

2004-08-24

Terminated

2005-07-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34305. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.