CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
Legacy Smartbase, Ne 3.0d 1mml recalled by Implant Direct Sybron
Implant Direct Sybron Manufacturing is recalling Legacy Smartbase, Ne 3.0d 1mml, distributed nationwide in the US. The recall was initiated on 2 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2037-2023
- FDA event ID
- 92415
- Recalling firm
- Implant Direct Sybron Manufacturing, Westlake Village, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 May 2023
- FDA classified
- 29 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 May 2023 | Recall initiated by company | |
| 29 Jun 2023 | Classified by FDA | +58 days |
| 5 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Product as listed by the FDA
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;
Where it was distributed
US Nationwide distribution in the states of FL, ID, TX, CA.
Questions about this recall
Why was it recalled?
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Which lots are affected?
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;
Where was it sold?
US Nationwide distribution in the states of FL, ID, TX, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Implant Direct Sybron Manufacturing
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Drill Stop Kit recalled by Implant Direct Sybron | Implant Direct Sybron Manufacturing | Other | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD recalled | Implant Direct Sybron Manufacturing | Packaging Defects | Nationwide |
| Device | CLASS II | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform recalled | Implant Direct Sybron Manufacturing | Device Malfunction | CA |
| Device | CLASS II | Implant Direct, CE recalled | Implant Direct Sybron Manufacturing | Packaging Defects | 22 states |
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