The Recall Desk
LowFDA (Devices)·Z-0924-2020·Announced 2020-02-12

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.

What this means for you

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.
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

Distributed in 2 states:

Same manufacturer · Jjgc Industria E Comercio De Materials Dentarios Sa

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