Z-2074-2015Class II

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No...

Name: Z-2074-2015 Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No...
Creator: Nobel Biocare Usa Llc
Published: 2015-06-22
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2015-06-22 / Terminated

FDA source

Nobel Biocare Usa Llc began a recall of Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit)... on 2015-06-22. FDA classified it as Class II and gives the reason as "One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2074-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-22
Posted: 2015-07-15
Terminated: 2015-09-18
Recalling firm: Nobel Biocare USA LLC
Product: Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
FDA root cause: Under Investigation by firm
Action: A customer notification letter dated 6/22/15 will be sent to all customers who purchased the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended. The letter provides the problems identified and the actions to be taken. Customers are instructed to complete the acknowledgement form and return it to their local Nobel Biocare Subsidiary with the affected instrument. Customers with the affected instrument that is a part of a kit, Nobel Biocare Representative will contact them directly. Customers with any remaining questions, are instructed to contact their Nobel Biocare Representative.
Quantity in commerce: 149 units total
Distribution: Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Product codes and lots: Article No. 37882, Batch No. 96149; Article No. 37508, Batch No. 814929, 815096, 815140, and 855021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2074-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

Product code NDP

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)