The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0564-2016·Announced 2016-01-06

Biomet 3i Recalls Radiographic Transparencies Due to Undersized Images

Biomet 3i is recalling 686 radiographic transparencies because the images are undersized, which may affect dental implant measurements.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a defect that may lead to measurement errors but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.

Plain-English summary

Biomet 3i, LLC is recalling 686 units of Radiographic Transparency for Certain and External Connection Tapered Implants (Model Number: ART 1036, Rev. C 03/13). These products are images that assist with measurements for dental implants.

The recall was initiated because the images contained within the radiographic transparencies are undersized. This defect may impact the accuracy of measurements taken using these tools.

The affected units were distributed worldwide, including in the United States (specifically CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV, and Hawaii) and in Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan, and Uruguay. Healthcare professionals and consumers should stop using these specific transparencies and contact Biomet 3i for further instructions.

The recalled product

Product
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
686

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 (3)

  • Model Number: ART 1036
  • Rev. C 03/13
  • Purchase Order # 184427.

Distribution

Distributed in 16 states:

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