Recall Z-0658-2020
Medtronic Navigation, Inc. · initiated October 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Codes / lots: Lot Numbers: 0009665221 0009709452 0009960538
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 taken
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.
Details
- Recall number
- Z-0658-2020
- Initiated
- October 30, 2019
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 12 disposable biopsy needles
- 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…
- Recalling firm
- Medtronic Navigation, Inc., Louisville, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0657-2020 Class II | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there… | 10/30/2019Open, Classified |
| Z-0659-2020 Class II | Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there… | 10/30/2019Open, Classified |