Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
Brand
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK is recalling Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at W due to Packaging weakness may compromise sterility and instructions for use are inadequate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging weakness may compromise sterility and instructions for use are inadequate.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026