Recall record at a glance
| Official record | Z-1168-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | W&H DENTALWERK BUERMOOS GMBH |
| Report date | Feb 28, 2024 |
| Recall initiation date | Jan 16, 2024 |
| Quantity | 160 pieces |
| Location | BUERMOOS, N/A, Austria |
Official product description
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Why the product was recalled
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 information
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Philippines, Sweden.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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