Recall Z-0924-2020— Jjgc Industria E Comercio De Materials Dentarios Sa
Class II · Terminated
Class II FDA medical device recall by Jjgc Industria E Comercio De Materials Dentarios Sa, initiated 2019-12-23, terminated 2021-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.. Reason: The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill"..
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-23
- Terminated
- 2021-06-01
- Firm location
- Curitiba, N/A, Brazil
Product description
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Reason for recall
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
Data sourced from openFDA. This site is unofficial and independent of the FDA.