Z-0352-2018Class II

Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

Name: Z-0352-2018 Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Creator: Medtronic Sofamor Danek USA Inc
Published: 2017-12-06
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2017-12-06 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R on 2017-12-06. FDA classified it as Class II and gives the reason as "Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0352-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-06
Posted: 2018-01-14
Terminated: 2019-11-04
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Product code: OAR Injector, Vertebroplasty (Does Not Contain Cement)
Reason for recall: Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following: "If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel within your facility as appropriate, and maintain a copy of this notice in your records. 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 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product."
Quantity in commerce: 3,319 units
Distribution: US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Product codes and lots: UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0352-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0352-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code OAR

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)