Z-0839-2015Class II

Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental...

Name: Z-0839-2015 Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental...
Creator: Instradent USA, Inc.
Published: 2014-08-11
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2014-08-11 / Terminated

FDA source

Instradent USA, Inc. began a recall of Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in... on 2014-08-11. FDA classified it as Class II and gives the reason as "Product not approved for use in the US". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0839-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-11
Posted: 2014-12-22
Terminated: 2015-02-06
Recalling firm: Straumann USA, LLC
Product: Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Product not approved for use in the US
FDA root cause: No Marketing Application
Action: Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275. For questions regarding this recall call 855-412-8883, ext 6366.
Quantity in commerce: 13 units
Distribution: Nationwide Distribution including AZ, CA, NY, and MA.
Product codes and lots: Lot Number: 800115427

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0839-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0839-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-22

Product code DZE

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)