Z-2828-2020Class II

NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 -

Name: Z-2828-2020 NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 -
Creator: Nobel Biocare Services Ag
Published: 2020-07-20
License: https://open.fda.gov/license/

Nobel Biocare Services AG / initiated 2020-07-20 / Terminated / root cause: manufacturing process

FDA source

NOBEL BIOCARE SERVICES AG began a recall of NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone... on 2020-07-20. FDA classified it as Class II and gives the reason as "Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2)...". 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-2828-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-20
Posted: 2020-08-20
Terminated: 2021-05-12
Recalling firm: Nobel Biocare Services AG
Product: NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 07/20/20, Urgent Medical Device Recall notices were emailed to customers who were asked to do the following: 1. Inspect your stock and confirm that both the cap label and the vial label indicate 4.3x10mm. 2. Quarantine devices with cap label 5.0x8mm. 3. Complete attached Customer Acknowledgment Form, even if you do not have any affected stock, and return it to the recalling firm via email. 4. Return all incorrectly labeled devices to the firm. Correctly labeled devices do not need to be returned. 5. Ensure relevant staff members are informed of this recall. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall by providing a copy of this letter. 6. Firm will replace returned affected devices. If you require any further information or support, please contact your local customer support representative at 714-282-4800 ext. 1527.
Quantity in commerce: 188
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of FL and NY and the countries of Albania and Hong Kong.
Product codes and lots: Lot: 13084072, UDI: (01)07332747073584(10)13084072(17)240525

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2828-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2828-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-20

Product code DZE

K073142Class IINobelreplace Hexagonal ImplantNobel Biocare USA, LLC / cleared 2008-01-11

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)