AxiEM" Non-Invasive Patient Tracker
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- December 15, 2022
- Posted
- January 30, 2023
- Recall Number
- Z-1039-2023
- Quantity
- 1,867 devies
- Firm Location
- Louisville, CO
Reason for Recall
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
Distribution
Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of Japan.
Lot / Code Info
Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00763000588380 Lot Number: 220728I 220729 Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00643169608252 Lot Number: 220728I
Root Cause
Process control
Action Taken
On 12/15/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail courier informing customers is recalling two specific lots of AxiEM Non-Invasive Patient Trackers due to the potential for verification failure of navigation instruments during a Functional Endoscopic Sinus Surgery procedure. Customer are instructed: 1. Do NOT use any impacted product. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. Their Medtronic Sales Representative can assist in initiating the return of the product as necessary. 3. Complete the Customer Confirmation Form enclosed with this letter (even if they have no product to return), acknowledging that they have received this information, and email the completed form to Medtronic at neuro.quality@medtronic.com. 4. If the affected devices have already been utilized and/or discarded, the firm is still asking that customers complete and return the Customer Confirmation Form detailing that information. For questions, contact Medtronic Sales Representative or Medtronic Technical Services at 1-888-826-5603 or via email at rs.navtechsupport@medtronic.com.