Biomet 3i Healing Abutments Recalled for Incorrect Label Color Coding
Biomet 3i is recalling 6 units of Bellatek Encode Healing Abutments because the labels have incorrect color coding, though the identifiers are correct.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging/labeling issue (incorrect color coding) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Biomet 3i, LLC is recalling 6 units of BIOMET 3i Certain Bellatek Encode Healing Abutments. These are temporary dental abutments used to maintain soft tissue openings during the healing process prior to restoration. The specific model number is IEHA458 and the lot number is 1167545.
The recall was initiated because the labels on these units have incorrect color coding. The source text notes that the identifiers on the labels are correct, but the color coding is wrong. The affected units were distributed to New Hampshire and Texas.
Consumers and healthcare providers who have these specific units should stop using them and contact Biomet 3i, LLC for instructions on how to return or dispose of the product.
The recalled product
- Product
- 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.
- Manufacturer
- Biomet 3i, LLC
- Hazard
- Affected units
- 6
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 (2)
- Model Number IEHA458
- Lot number: 1167545.
Distribution
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