Reported Oct 11, 2017 · Terminated
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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?
- Implant Direct Swish Duo-Grip Healing Collar
- Length3mm
- Platform4.8 mm, Rx only, Sterile Dental Implant component
- Lot codes and dates
Product Code 9048-13HLot No. 81080
- Amount recalled
- 50 units
Where it was sold
Why it was recalled
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
This product could cause temporary or reversible health problems — stop using it.
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