Reported Nov 10, 2021 · Ongoing
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
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?
ImplantDirectREF 834713Legacy 2 Implant 4.7mmD x 13mmL4.5mmD Platform
- Lot codes and dates
- lot # 166300 /
- UDI10841307101796
- Amount recalled
- 83 implants
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Packaged dental implant contains a different size then the size declared on the labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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