Recall Z-2047-2017 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek USA Inc
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
| Date | Apr 13, 2017 |
| Status | Terminated |
| Reason | Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle. |
| Root cause | Under Investigation by firm |
| Action | Medtronic sent an Urgent : Field Safety Corrective Action dated April 13, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com, or fax to 763-367-8134. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. |
| Quantity | 36 units |
| Distribution | US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.