Jjgc Industria E Comercio De Materials Dentarios Sa recalls Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
- Recall date
- December 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0924-2020
- FDA classification
- Class II
- Brand / firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Sold / distributed
- Distributed to consignees in CA and PA.
Why it was recalled
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
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