Thommen Medical AG: Medical Device Recall in 2019 - (Recall #: Z-1390-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 3, 2019

Date Posted: May 29, 2019

Recall Number: Z-1390-2019

Event ID: 82675

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).

Status: Terminated

Product Quantity: 15 US

Code Information:

Lot number:17415 UDI: 07640182640705

Distribution Pattern:

US Nationwide distribution in the state of OH.

Voluntary or Mandated:

Voluntary: Firm initiated