Reported Jul 5, 2023 · Ongoing
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…
Implant Direct Sybron Manufacturing LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Implant Direct Sybron Manufacturing LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171
Is this the product you have?
5 products · 7 lot codes
8730-81NELEGACY SMARTBASE, NE 3.0D 1MML
- UDI-DI
10841307123002
2 recalled lot codes
92637131309
8730-82NELEGACY SMARTBASE, NE 3.0D 2MML
- UDI-DI
10841307123019
2 recalled lot codes
92638163063
8735-80NNELEGACY SMARTBASE NARROW NE 3.5D
- UDI-DI
10841307123026
1 recalled lot code
160542
8745-80NNELEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D
- UDI-DI
10841307123033
1 recalled lot code
15004780
Page 1 of 2
- Amount recalled
- 29
Where it was sold
Why it was recalled
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
This product could cause temporary or reversible health problems — stop using it.
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