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Terminated

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.

FDA Recall Z-1007-2017 · Posted 2017-01-11

Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2016-12-12
Date Terminated2017-05-19
Product Quantity111 devices

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.

Firm Action

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.

Root Cause

Process change control

Distribution Pattern

US Nationwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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