FDA recall Z-1390-2019

Thommen Medical AG · Class II · device

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.

Reason for recall

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).

Distribution

US Nationwide distribution in the state of OH.

Key facts

Status
Terminated
Initiation date
2019-04-03
Report date
2019-05-29
Termination date
2019-08-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bettlach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2019