FDAFDA · Food and drugs·Recall number Z-2047-2017
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Published May 17, 2017 · Recall initiated: April 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
- Lot
- Lot number 0521148W, Exp. 10/21/2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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