LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW
Summary
The FDA issued a Class II for LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, by Implant Direct Sybron Manufacturing LLC. Reason: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established..
Details
Source
Device Recall
External ID
Z-2037-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
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;
Lot/Code Info: 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;
Quantity Affected: 29
Reason for Recall
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
Distribution
US Nationwide distribution in the states of FL, ID, TX, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-02
Company
Westlake Village, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Implant Direct Sybron Manufacturing LLC has 7 FDA actions in our database, including 4 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Implant Direct Sybron Manufacturing LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Implant Direct Sybron Manufacturing LLC have FDA actions?
Implant Direct Sybron Manufacturing LLC has 7 FDA actions in our database, including 4 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2037-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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