Reported May 29, 2019 · Terminated
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The…
Thommen Medical AG
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: Thommen Medical AG · Eschenweg 3 · Bettlach, N/A · N/A
Is this the product you have?
- Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8
- mm Article number3.04.090 -
- Product UsageThe adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically
- Lot codes and dates
- Lot number17415
- UDI07640182640705
- Amount recalled
- 15 US
Where it was sold
- Nationwide
- OH
Why it was recalled
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
This product could cause temporary or reversible health problems — stop using it.
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