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.
This recall has been terminated (originally issued January 11, 2017).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- December 12, 2016
- Posted
- January 11, 2017
- Terminated
- May 19, 2017
- Recall Number
- Z-1007-2017
- Quantity
- 111 devices
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution.
Lot / Code Info
lot number 150626B
Root Cause
Process change control
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.