Recalls / —

—#44016

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

Lot Nos. 75258083 and 7521663501

Why it was recalled

The product was not fully assembled prior to packaging.

Root cause (FDA determination)

Other

Action the firm took

The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.

Recalling firm

Firm

Wright Medical Technology Inc

Address

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

Distribution

Distribution pattern

Nationwide and PR

Timeline

Recall initiated

2006-01-03

Posted by FDA

2006-02-16

Terminated

2007-01-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.