Thommen Medical AG recalls Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapte…

Recall date

April 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1390-2019

FDA classification

Class II

Brand / firm

Thommen Medical AG

Sold / distributed

US Nationwide distribution in the state of 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.