Z-2529-2018Class II

Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614

Name: Z-2529-2018 Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614
Creator: Nobel Biocare Usa Llc
Published: 2018-03-16
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2018-03-16 / Terminated / root cause: manufacturing process

FDA source

Nobel Biocare Usa Llc began a recall of Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for... on 2018-03-16. FDA classified it as Class II and gives the reason as "The product label has missing information, such as the lot number and expiration date, as well as other information". 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-2529-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Posted: 2018-07-23
Terminated: 2018-09-11
Recalling firm: Nobel Biocare USA LLC
Product: Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: The product label has missing information, such as the lot number and expiration date, as well as other information.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Nobel Biocare sent an Urgent Quality Message letter dated March 13, 2018 via email to the U.S. consignees. The letter identified the affected product, problem and actions to be taken. For question contact customer service department at 800-322-5001.
Quantity in commerce: 74 units were distributed to the U.S.
Distribution: Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.
Product codes and lots: Lot #1270802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2529-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2529-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-23

Product code NHA

K072570Class IINobelactive Multi Unit AbutmentNobel Biocare AB / cleared 2007-12-28

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)