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Terminated

Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.

FDA Recall Z-0114-2008 · Posted 2007-11-07

Recalling FirmWarsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-09-04
Date Terminated2009-07-14
Product Quantity22,632

Reason for Recall

Packaging weakness may compromise sterility and instructions for use are inadequate.

Firm Action

Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.

Root Cause

Package design/selection

Distribution Pattern

Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930511STEALTH SURGICAL IRRIGATOR ASPIRATORW. J. Medical Instruments, Inc. · 1993-06-25

Official Source

View FDA Recall →

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

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