Recall Z-1390-2019— Thommen Medical AG
Class II · Terminated
Class II FDA medical device recall by Thommen Medical AG, initiated 2019-04-03, terminated 2019-08-12. FDA's recall record names no specific 510(k) clearance for this event. 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: 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)..
- Recalling firm
- Thommen Medical AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-03
- Terminated
- 2019-08-12
- Firm location
- Bettlach, N/A, Switzerland
Product description
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.