Biomet 3i Recalls Dental Implants Due to Missing Internal Threading
Biomet 3i is recalling 227 Osseotite Tapered Certain Implants because a small percentage are missing internal threading. The devices were 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device (missing internal threading) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet 3i, LLC is recalling 227 units of the Osseotite Tapered Certain Implant, Model # INT510, Lot # 2011090751. The recall was initiated because a small percentage of the devices are missing the internal threading.
These dental implants are 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 affected units were distributed worldwide, including in the United States and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.
The source text does not specify specific actions for consumers or patients. Healthcare providers and patients should contact Biomet 3i, LLC for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are 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 with multiple…
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 227
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 # INT510
- Lot # 2011090751
Distribution
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Similar recalls
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