medical Class II Updated 2019-05-29

Thommen Medical AG recalls Adapter for handpiece, guided, reusable, for guide sleeve

Recalled Product

Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The 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.


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number:17415 UDI: 07640182640705
View official government recall

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