Biomet 3i Recalls Mislabelled UCLA Dental Abutment Cylinders
Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.
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, but the source text describes a labeling error without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Biomet 3i, LLC is recalling 61 pieces of the UCLA Abutment Hexed Castable Cylinder 3.4mm (Model # MUCC1C, Lot # 1186054). These dental implant accessories are used to support prosthetic devices in patients with missing teeth.
The recall was initiated because the product was incorrectly labeled and distributed. Specifically, the MUCC2, non-hexed, castable abutment cylinders were labeled and distributed as MUCC1C, hexed, castable abutment cylinders for this single lot. The affected units were distributed worldwide, including in Italy and Uruguay.
The source text does not specify any reported injuries or illnesses associated with this labeling error. Consumers and healthcare providers should verify the model and lot numbers of their inventory against the recall details provided by the manufacturer.
The recalled product
- Product
- UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
- Manufacturer
- Biomet 3i, LLC
- Hazard
- Affected units
- 61
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)
- Model # MUCC1C LOT # 1186054
Distribution
Distribution scope not specified by the agency.
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