Reported Jul 11, 2018 · Terminated
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
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?
REPLANT 5.0mmD ABUTMENTPart number 6050-52-60
- Lot codes and dates
- Lot numbers
4535366011and 75850
- Lot numbers
- Amount recalled
- 60 units
Where it was sold
Why it was recalled
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
This product could cause temporary or reversible health problems — stop using it.
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