Reported Aug 1, 2018 · Terminated
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of…
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 · Thousand Oaks, CA · 91362
Is this the product you have?
- ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
- Lot codes and dates
- Lot #87837
- Amount recalled
- 124 units
Where it was sold
Why it was recalled
The main vial label lists the incorrect part number, but the cap label is correct.
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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