The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2143-2019·Announced 2019-08-14

Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect

Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

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 source text describes a manufacturing defect without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet 3i, LLC is recalling 2 units of CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3. These products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandilla.

The recall was initiated because, during manufacturing, the screw stop ledge was not made to specification and location within the abutment. This defect results in the screw head seating deeper in the abutment with no positive stop.

The affected units were distributed nationwide and in Puerto Rico, Canada, and Australia. The specific lot numbers are 8442561-2 and 8442561-3. Consumers and healthcare providers should check their inventory for these specific item numbers and lot codes.

The recalled product

Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant Abutment
Hazard
Affected units
2

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Biomet 3i, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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