Legacy Smartbase, Ne 3.0d 1mml, Ref: 8730-81ne recallZ-2037-2023 · Implant Direct Sybron Manufacturing LLC · initiated May 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
FDA root cause category: No Marketing Application
What the company is doing
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
Recall details
- Recall number
- Z-2037-2023
- Status
- Open, Classified
- Initiated by the company
- May 2, 2023
- Posted by the FDA
- Jun 29, 2023
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Quantity
- 29
- Product code
- NHA
- FDA submissions
- K223535
- Distribution
- US Nationwide distribution in the states of FL, ID, TX, CA.
Product description
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;
Code information (models, lots, serial numbers)
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;
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- Legacy™ SMARTbase, NE 8730-81NEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8730-82NEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, Narrow, NE 8735-80NNEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, Narrow, NE 8745-80NNEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8735-82NEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
- Legacy™ SMARTbase, NE 8745-82NEImplant Direct Sybron Manufacturing LLC · Abutment, Implant, Dental, Endosseous1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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