Dental Implant Abutments Recalled Due to Lack of FDA Clearance
Implant Direct Sybron is recalling LEGACY SMARTBASE dental abutments distributed without FDA clearance. Performance characteristics have not been adequately established.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves medical devices distributed without FDA clearance with inadequately established performance characteristics, representing a theoretical risk of harm. No illnesses or injuries have been reported.
Plain-English summary
Implant Direct Sybron Manufacturing LLC is recalling LEGACY SMARTBASE dental implant abutments in multiple configurations. These devices were distributed without FDA clearance, and their performance characteristics have not been adequately established.
The recalled abutments include multiple reference numbers: 8730-81NE, 8730-82NE, 8735-80NNE, 8735-82NE, 8745-80NNE, and 8745-82NE. A total of 29 units were distributed nationwide to Florida, Idaho, Texas, and California. Patients or healthcare providers who have received or used these abutments should contact Implant Direct Sybron Manufacturing LLC or their healthcare provider for guidance on whether their device may be affected.
The recalled product
- 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…
- Manufacturer
- Implant Direct Sybron Manufacturing LLC
- Category
- Medical Device — Dental Implant
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
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