Z-2047-2017Class II

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

Name: Z-2047-2017 Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Creator: Medtronic Sofamor Danek USA Inc
Published: 2017-04-13
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2017-04-13 / Terminated / root cause: packaging

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only on 2017-04-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2047-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-13
Posted: 2017-05-05
Terminated: 2017-12-28
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 36 units
Distribution: US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Product codes and lots: Lot number 0521148W, Exp. 10/21/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2047-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2047-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-05

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)