Z-2237-2016Class II

Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form...

Name: Z-2237-2016 Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form...
Creator: Nobel Biocare Usa Llc
Published: 2016-06-22
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2016-06-22 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare Usa Llc began a recall of Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed... on 2016-06-22. FDA classified it as Class II and gives the reason as "Incorrect top label on an implant package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2237-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-07-19
Terminated: 2016-09-06
Recalling firm: Nobel Biocare USA LLC
Product: Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Incorrect top label on an implant package.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Nobel Biocare sent a customer notification letter dated June 23, 2016 to all affected customers to inform them that Nobel Biocare has detected that the lot#13030677 of Replace Select Tapered TiU NP 3.5 x 11.5 mm (product#36105) carries an incorrect top label. The letter informs the customers that the incorrect top label states "Replace NP 3.5 x 11.5 CC" (ie. Conical Connection). The product, Replace Select Tapered TiU NP 3.5 x 11.5 mm, has a Tri-lobe connection. Customers were instructed to complete the attached Quality Message Acknowledgement form. Customer with questions were instructed to contact customer service at 714-282-4808.
Quantity in commerce: 53 units total (33 units in US)
Distribution: Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Product codes and lots: 13030677

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

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)