BUERMOOS, N/A, Austria
W&H DENTALWERK BUERMOOS GMBH recalls
1 recall recorded since 2018, most recently on 16 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 January 2024
- Reason
- 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1168-2024
- W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.