Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Recall
- Recall Number
- Z-2047-2017
- Event Number
- 77049
- Firm
- Medtronic Sofamor Danek USA Inc
- FEI Number
- 1000477302
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 13, 2017
- Terminated
- December 28, 2017
- Address
- 1800 Pyramid Pl, Memphis, TN, 38132-1703
Description
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
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.
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 [email protected], or fax to 763-367-8134. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact our Post-Market Quality team at 901-399-3197. For further questions, please call (901) 344-1435.
US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
36 units