Class 2 Device Recall SNT Disposable Biopsy Needle

• Date Initiated by Firm: October 30, 2019
• Create Date: December 06, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0659-2020
• Recall Event ID: 84191
• 510(K)Number: K971247
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
• Code Information: Lot Numbers: 0009754921 0009921274 0009940846 0009921273 0009921276 0009952564
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 826 Coal Creek Cir; Louisville CO 80027-9710
• For Additional Information Contact: Todd Hansell; 720-890-3241
• Manufacturer Reason for Recall: The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
• FDA Determined Cause: Process control
• Action: On 10/24/2019, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to consignees via FedEx. The customer notification letter as consignees to do the following: 1. Identify, segregate, and quarantine affected products within your inventory 2. Complete the Customer Confirmation Form. Return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. 3. Contact Medtronic at 1-888-826-5603 to receive a return materials authorization (RMA) and schedule replacement product. Return affected products to: 4. Medtronic Product Services, Attention: RMA #, 1480 Arthur Ave Louisville, CO 80027 5. If you have questions E-mail Medtronic at RS.NavTechSupport@Medtronic.com or call 1-888-826-5603.
• Quantity in Commerce: 1 disposable Biopsy Needle
• Distribution: US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming, OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HAW and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.