Recall Z-0114-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
| Date | Nov 7, 2007 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | Packaging weakness may compromise sterility and instructions for use are inadequate. |
| Root cause | Package design/selection |
| 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. |
| Quantity | 22,632 |
| Distribution | Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930511 | STEALTH SURGICAL IRRIGATOR ASPIRATOR W. J. Medical Instruments, Inc., Jun 25, 1993 |