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;
Reported: July 5, 2023 Initiated: May 2, 2023 #Z-2037-2023
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;
Reason for Recall
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Details
- Recalling Firm
- Implant Direct Sybron Manufacturing LLC
- Units Affected
- 29
- Distribution
- US Nationwide distribution in the states of FL, ID, TX, CA.
- Location
- Westlake Village, CA
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Implant Direct Sybron Manufacturing LLC. Units affected: 29.
Why was this product recalled? ▼
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2037-2023.
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