Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
FDA Recall Z-0992-05 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.