—#154880

Product

Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot number 0521148W, Exp. 10/21/2021

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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. 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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.

Timeline

Recall initiated: 2017-04-13
Terminated: 2017-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.