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Thommen Medical AG recalls Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapt
Recalled May 29, 2019 · FDA recall Z-1390-2019 · Thommen Medical AG
Hazard
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). · FDA Class II
Units
15 US
Sold at
US Nationwide distribution in the state of OH.
Description
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).
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.
Manufacturer(s)
Thommen Medical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →