Z-1856-2020Class II

Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous...

Name: Z-1856-2020 Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous...
Creator: Nobel Biocare Usa Llc
Published: 2019-08-09
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2019-08-09 / Terminated / root cause: manufacturing process

FDA source

Nobel Biocare Usa Llc began a recall of Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained... on 2019-08-09. FDA classified it as Class II and gives the reason as "Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened...". 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-1856-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-09
Posted: 2020-05-04
Terminated: 2021-12-01
Recalling firm: Nobel Biocare USA LLC
Product: Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Recall Letters were sent to U.S. customers via the U.S Postal Service and OUS customers via email beginning on August 9, 2019. This communication notified customers that the firm had identified a packaging issue affecting six product codes and a total of 7 lots of medical devices (titanium abutments) where the packages of abutment lots may contain an incorrect screw. Customers were informed that while the screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, customers are instructed to retighten the abutment with the correct screw. Customers were requested to: i1) identify all devices of the affected lots which they have in stock, 2) not to use the affected devices, 3) complete the Customer Acknowledgement Form and, 4) return it to Nobel Biocare via email at [email protected] or by fax to 714-282-5073, within 5 days of receipt of the Urgent Medical Device Recall Letter. Customers were instructed to return all devices from affected lots to Nobel Biocare, Attn: Returns PFA1914, 22715 Savi Ranch Parkway, Yorba Linda, CA 92887. The Urgent Medical Device Recall Letter notes that the manufacturer has reviewed the packaging process, has implemented corrective actions and will initiate preventive actions. The letter requests that customers pass the letter on to all those who need to be aware within their organizations or to any organization where the potentially affected devices have been transferred. Customers were instructed to contact their customer support representative at 1-800-322-5001, ext. 1527, if they require further information or support.
Quantity in commerce: 238 pieces
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
Product codes and lots: Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1856-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1852-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1853-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1854-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1855-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1856-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1857-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04

Product code DZE

K925762Class IIBranemark System Self-Tapping FixtureNobelpharma USA, Inc. / cleared 1993-10-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)