Z-2037-2023Class II

Legacy Smartbase, Ne 3.0D 1Mml, Ref: 8730-81Ne; Legacy Smartbase, Ne 3.0D 2Mml, Ref 8730-82Ne; Legacy...

Name: Z-2037-2023 Legacy Smartbase, Ne 3.0D 1Mml, Ref: 8730-81Ne; Legacy Smartbase, Ne 3.0D 2Mml, Ref 8730-82Ne; Legacy...
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2023-05-02
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2023-05-02 / Open, Classified

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY... on 2023-05-02. FDA classified it as Class II and gives the reason as "Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2037-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-02
Posted: 2023-06-29
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Legacy Smartbase, Ne 3.0D 1Mml, Ref: 8730-81Ne; Legacy Smartbase, Ne 3.0D 2Mml, Ref 8730-82Ne; Legacy Smartbase Narrow Ne 3.5D, Ref: 8735-80Nne; Legacy Smartbase, Ne 3.5D 2Mml, Ref: 8735-82Ne Legacy Smartbase Narrow Ne 4.5D, Ref: 8745-80Nne; Legacy Smartbase. Ne 4.5D, Ref: 8745-82Ne;
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
FDA root cause: No Marketing Application
Action: On 5/2/23, correction notices were emailed to customers who were asked to do the following: 1) Contact recalling firm to arrange return of affected product that has not yet been placed in the patient. 2) Share this notice with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. 3) Complete and return the acknowledgement form to Questions, complaints, or adverse events can be reported to the recalling firm via phone 1-888-649-6425 (Monday - Friday, 5AM - 5PM PST) or through their website: https://www.implantdirect.com/en-us
Quantity in commerce: 29
Distribution: US Nationwide distribution in the states of FL, ID, TX, CA.
Product codes and lots: REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/10841307123026/160542; 8735-82NE/10841307123064/15002360; 8745-80NNE/10841307123033/15004780; 8745-82NE/10841307123071/182029;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2037-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2037-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code NHA

K223535Class IISMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC / cleared 2023-06-20

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)