AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then plac
FDA device recall Z-1007-2017 · posted 2017-01-11 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation System with Touch N Go Pointer Probes for patient registration.
- Action taken
- The firm, Medtronic, sent an "URGENT: MEDICAL DEVICE RECALL" letter on 12/12/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for any affected products, quarantine them for return to Medtronic; complete and return the CUSTOMER RESPONSE FORM by email at RS.NavFCA@medtronic.com or fax to Medtronic Technical Services at 651-367-7075 (even if you do not have affected product); and contact Medtronic Technical Services at 1-800-595-9709 to get a return material authorization (RMA) and arrange for their return and no charge replacements. If you have any questions regarding this communication, please contact Medtronic Technical Services at (800) 595-9709.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 111 devices
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2016-12-12
- Date posted
- 2017-01-11
- Date terminated
- 2017-05-19
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833) | Medtronic Navigation, Inc. | 2015-03-25 |