FDA Device

Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.

Hazard

The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.

What You Should Do

Remedy

The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.

Products

Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Brand
Ortho Development Corporation
UPC
Part # 252-0300, Lot # W007919.

Units Affected

27