Recall Z-1168-2024— W&H DENTALWERK BUERMOOS GMBH
Class II · Ongoing
Class II FDA medical device recall by W&H DENTALWERK BUERMOOS GMBH, initiated 2024-01-16. It names one FDA 510(k) clearance: K080939. Product: W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000. 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.
- Recalling firm
- W&H DENTALWERK BUERMOOS GMBH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-16
- Firm location
- BUERMOOS, N/A, Austria
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.