Curitiba, N/A, Brazil
Jjgc Industria E Comercio De Materials Dentarios Sa recalls
2 recalls recorded since 2018, most recently on 11 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 October 2021
- Terminated
- 16 January 2024
- Reason
- 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0203-2022
- GM Helix Acqua Implant 3.5x10, Article No. 140.944
Terminated Class II Medical devices
- Recall started
- 23 December 2019
- Terminated
- 1 June 2021
- Reason
- The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
- Distribution
- Distributed to consignees in CA and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0924-2020
- Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
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.