FDAClass IIMay 17, 2017

Medtronic PAK Needle Beveled and Trocar Tips recall

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

Why was Medtronic PAK Needle Beveled and Trocar Tips 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number 0521148W, Exp. 10/21/2021

Product
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
36 units
Distribution
US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Recall date
May 17, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls