FDA Device

Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.

Hazard

The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.

What You Should Do

Remedy

Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.

Products

Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
Brand
Warsaw Orthopedic, Inc.
UPC
All lots.