Biomet 3i Recalls Low Profile Abutments Due to Labeling Errors
Biomet 3i is recalling Low Profile Abutments because some packages labeled as Hexed Castable Cylinders may contain Non-Hexed Castable Cylinders.
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 hazard is a labeling error (wrong model in package) rather than a contamination or structural defect, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Biomet 3i, LLC is recalling 611 units of the Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. The recall was initiated because some packages labeled as LPCCC1, Hexed Castable Cylinder, may actually contain LPCCC2, Non-Hexed Castable Cylinders.
The affected products are distributed worldwide, including in the United States, Spain, France, Germany, Switzerland, and Australia. The specific lots involved are 2010100001, 2010080684, and 2010090191. These devices are intended to be used to produce a definitive casting for dental restoration.
Healthcare professionals and patients should check their inventory for these specific lot numbers and contact Biomet 3i for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing…
- Manufacturer
- Biomet 3i, LLC
- Hazard
- Affected units
- 611
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)
- Lots: 2010100001
- 2010080684
- and 2010090191
Distribution
Distribution scope not specified by the agency.
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