# FDA recall Z-1390-2019

> **Thommen Medical AG** · Class II · device recall initiated 2019-04-03.

## 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

- **Recall number:** Z-1390-2019
- **Recalling firm:** Thommen Medical AG
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1390-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1390-2019. Source: US FDA. Licensed CC0.

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