The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2158-2012·Announced 2012-08-15

Biomet 3i Recalls Dental Implants Due to Shallow Internal Hex Depth

Biomet 3i is recalling specific dental implants because the internal hex depth is too shallow, which may prevent components from fully engaging the implant.

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 may prevent proper engagement of components, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet 3i, LLC is recalling the Full Osseotite Tapered Certain Implant, reference IFNT611, size 6 x 11.5mm. The recall affects 240 units from Lot Number 2011110798. These implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in various dental restorations.

The recall is being issued because the depth of the implant's internal hex is too shallow. This condition may prevent the driver, cover screw, or abutment from fully engaging the implant. The affected units were distributed worldwide, including in the United States, UK, France, Canada, Mexico, Poland, Lebanon, and Hong Kong.

Healthcare professionals and patients who have received these implants should contact Biomet 3i for further instructions regarding the recall and potential replacement or repair options.

The recalled product

Product
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical…
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant
Hazard
Affected units
240

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 Number 2011110798

Distribution

Distribution scope not specified by the agency.

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · structural defect

See all →

Similar recalls