Reported Nov 6, 2019 · Terminated
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI :…
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 Scan Adapter Assembly Replant
- platform for the following part numbers
6035-09PT-M (3.5mmD)/UDI : 108413071239346043-09PT-M (4.3mmD)/UDI : 10841307123941and 6050-09PT-M (5.00mmD)/
- UDI10841307123958
- Lot codes and dates
3 of 3 products · 3 lot codes
Recalled lot codes, grouped by product number Part numbers Lot Numbers 6035-09PTLot # 104539
6043-09PTLot # 104540
6050-09PTLot # 104511
- Amount recalled
- 107 Scan Adapters
Where it was sold
Why it was recalled
The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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