CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Neodent Tapered Guided Surgery Drill, Article No. recalled
Jjgc Industria E Comercio De Materials Dentarios is recalling Neodent Tapered Guided Surgery Drill, Article No. 103.436, distributed in California, Pennsylvania. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0924-2020
- FDA event ID
- 84709
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios, Curitiba, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2019
- FDA classified
- 31 Jan 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 23 Dec 2019 | Recall initiated by company | |
| 31 Jan 2020 | Classified by FDA | +39 days |
| 12 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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".
Product as listed by the FDA
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Where it was distributed
Distributed to consignees in CA and PA.
Questions about this recall
Is Neodent Tapered Guided Surgery Drill, Article No. 103.436 recalled?
Yes. Jjgc Industria E Comercio De Materials Dentarios recalled Neodent Tapered Guided Surgery Drill, Article No. 103.436 on 23 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0924-2020.
Why was it recalled?
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
Which lots are affected?
Lot WH723
Where was it sold?
Distributed to consignees in CA and PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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