Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2017 - (Recall #: Z-2047-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 13, 2017

Date Posted: May 17, 2017

Recall Number: Z-2047-2017

Event ID: 77049

Reason for Recall:

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated