AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Recall
- Recall Number
- Z-1007-2017
- Event Number
- 76060
- Firm
- Medtronic Navigation, Inc.
- FEI Number
- 1000517638
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- December 12, 2016
- Posted
- January 11, 2017
- Terminated
- May 19, 2017
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710
Description
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
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.
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 [email protected] 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.
US Nationwide Distribution.
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