Biomet 3i Recalls Dental Implants Lacking Internal Hex and Thread Features
Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.
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. The source text describes a manufacturing defect (missing features) but explicitly does not report any illnesses or injuries, fitting the criteria for a moderate severity score where the hazard is present but no harm has been reported.
Plain-English summary
Biomet 3i, LLC is recalling 178 units of the Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant. The recall was initiated because one of the dental implants does not have the internal hex feature, and one of the dental implants does not have the internal thread feature.
The affected product is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans. The distribution pattern includes worldwide distribution, specifically in the United States (MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC) and in Canada, Japan, Australia, Italy, Germany, France, Switzerland, Spain, Brazil, Uruguay, Singapore, Dominican Republic, Taiwan, Austria, Portugal, and the United Kingdom.
The source text does not specify the exact action consumers or healthcare providers should take, such as whether to stop use or return the product. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth…
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 178
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)
- IOSS415
Distribution
Part of a larger recall action
This product is one of 2 recalled by Biomet 3i, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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