Z-0992-05

Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018

Name: Z-0992-05 Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018
Creator: Warsaw Orthopedic, Inc.
Published: 2005-06-20
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2005-06-20 / Terminated / root cause: packaging

FDA source

Warsaw Orthopedic, Inc. began a recall of Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018 on 2005-06-20. The reason FDA records is "The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0992-05
Status: Terminated
Initiated: 2005-06-20
Posted: 2005-07-13
Terminated: 2006-02-08
Recalling firm: Warsaw Orthopedic, Inc.
Product: Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
Product code: HRX Arthroscope
Reason for recall: The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
Distribution: Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
Product codes and lots: All lots.

Product code HRX

K993021Class IIMetrx SystemSurgical Navigation Technologies, Inc. / cleared 1999-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)