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Terminated

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

FDA Recall Z-0991-05 · Posted 2005-07-13

Recalling FirmWarsaw Orthopedic, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2005-06-20
Date Terminated2006-02-08

Reason for Recall

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

Firm Action

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

Root Cause

Package design/selection

Distribution Pattern

Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993021METRX SYSTEMSurgical Navigation Technologies, Inc. · 1999-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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