Z-2375-2016Class II

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide...

Name: Z-2375-2016 Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide...
Creator: Nobel Biocare Usa Llc
Published: 2016-07-20
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2016-07-20 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare Usa Llc began a recall of Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and... on 2016-07-20. FDA classified it as Class II and gives the reason as "Incorrect drill protocol in the Instructions for Use (IFU)". 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-2375-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-08-09
Terminated: 2016-10-17
Recalling firm: Nobel Biocare USA LLC
Product: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
Product code: DZI Drill, Bone, Powered
Reason for recall: Incorrect drill protocol in the Instructions for Use (IFU)
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm, Nobel Biocare, sent "IMPORTANT-QUALITY MESSAGE" Field Correction Letters and response forms dated July 22, 2016. The letter describes the product, problem and actions to be taken and informs the customers that the titles of the IFU and the Manual are "NobelGuide for NobelParallel Conical Connection" (ID number 2002) and "Guided Surgery with Nobel Parallel Conical Connection" (ID number 79423). The Customers are instructed to review if you have a printed version of the IFU or the Manual related to the article and discard them; and to complete the attached "Quality Message Acknowledgement" form and fax to 714-998-9348 or email to: [email protected]. Customers are informed that an English version of the corrected IFU is attached to the letter and translated versions will be available on the Nobel Biocare website for electronic IFU's http://www.nobelbiocare.com/IFU within 30 days. If you have further questions, contact our customer service department at 714-322-5001.
Quantity in commerce: 231 kits
Distribution: Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
Product codes and lots: Article 38072-all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2375-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2375-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

Product code DZI

K990846Class IIAmorphous Diamond Coated DrillNobel Biocare Uas, Inc. / cleared 1999-06-10

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)