The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2140-2019·Announced 2019-08-14

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

Biomet 3i is recalling 3 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to improper function or injury, but the source text does not report any specific illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is recalling 3 units of CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3. These products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible.

The recall is due to a manufacturing defect where the screw stop ledge was not made to the correct specification and location within the abutment. This 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 8442784-1, 8442469-1, and 8442689-1. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - 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 Accessory
Hazard
Affected units
3

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)

  • Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1
  • 8442469-1/(01)00844868031130(10)8442469-1
  • 8442689-1/(01)00844868031130(10)8442689-1

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · structural defect

See all →

Similar recalls