Biomet 3i, LLC: Medical Device Recall in 2014 - (Recall #: Z-2594-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

Product Classification:

Class II

Date Initiated: June 25, 2014
Date Posted: September 17, 2014
Recall Number: Z-2594-2014
Event ID: 68915
Reason for Recall:

Identifiers on the label are correct but the label has the incorrect color coding.

Status: Terminated
Product Quantity: 6 units
Code Information:

Model Number IEHA458, Lot number: 1167545.

Distribution Pattern:

US Distribution to NH and TX.

Voluntary or Mandated:

Voluntary: Firm initiated