Z-2250-2020Class II

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 -

Name: Z-2250-2020 Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 -
Creator: Nobel Biocare Usa Llc
Published: 2019-05-28
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2019-05-28 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare Usa Llc began a recall of Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the... on 2019-05-28. FDA classified it as Class II and gives the reason as "Packaged dental implant healing abutments were found to contain the wrong size device". 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-2250-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2020-06-03
Terminated: 2021-02-09
Recalling firm: Nobel Biocare USA LLC
Product: Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - 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. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Packaged dental implant healing abutments were found to contain the wrong size device.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 5/28/2019, the firm mailed "Urgent Medical Device Recall" letters with an acknowledgement forms. The letter instructs the customers to: 1. Identify affected devices in your stock. 2. Do not use affected devices. 3. Complete and return the Customer Acknowledgment Form. 4. Return affected devices. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x 1527.
Quantity in commerce: 234 pieces globally, of which 16 were sent to the US.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.
Product codes and lots: Lot 13076845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2250-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2250-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-03

Product code DZE

K071370Class IINobelactive Internal Connection ImplantNobel Biocare AB / cleared 2007-08-03

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)