Recall Z-3058-2017 ยท PGW Ear, Nose, And Throat Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStat
| Date | Jun 29, 2017 |
| Status | Terminated |
| Reason | The instruments are not able to pass instrument verification which is performed prior to the use of each instrument. |
| Root cause | Device Design |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated June 25, 2017, via overnight mail on June 29, 2017, to all affected customers. Letters to foreign customers are being handled by geography-specific Regulatory Specialists. Customers were instructed examine their inventory for the affected product and immediately quarantine them for return for Medtronic. Customers with affected product were instructed to contact Medtronic Technical Services at 1-800-595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Customers were asked |
| Quantity | 6 kits |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153555 | EM ENT Navigated Suctions Medtronic Navigation, Inc., Apr 7, 2016 |