Neodent Tapered Guided Surgery Drill Recalled for Incorrect Laser Engraving
Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two Neodent Tapered Guided Surgery Drills because the laser engraving incorrectly identifies the model.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic labeling error (incorrect laser engraving) with no reported injuries or health hazards, fitting the criteria for a Low severity recall.
Plain-English summary
Jjgc Industria E Comercio De Materials Dentarios Sa is recalling two units of the Neodent Tapered Guided Surgery Drill, Article No. 103.436. The device is a dental burr with UDI 07899878030041.
The recall was initiated because the laser engraving on the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill." This is a labeling error regarding the product identification.
The affected units were distributed to consignees in California and Pennsylvania. The specific lot number is WH723. Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot WH723
Distribution
Related recalls
Same manufacturer · Jjgc Industria E Comercio De Materials Dentarios Sa
See all →- HighDental Implants Mislabeled as Smaller Size; Risk of Nerve Damage
FDA (Devices) · 2021-11-10
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateParagon 28 Gorilla Plating System Drill Recalled for Incorrect Packaging Label
FDA (Devices) · 2022-08-03
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
- LowSouthern Implants Recalls Dental Implants Due to Inner Labeling Error
FDA (Devices) · 2018-04-25
- HighSurgical drill guide may bend and produce metal shavings during use
FDA (Devices) · 2023-07-12
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
- ModerateTrilliant Surgical Recalls 3.5mm Aresenal Screw Drill Bits Due to Labeling Error
FDA (Devices) · 2020-05-13