Biomet 3i Recalls 92 Dental Implants Due to Packaging Error
Biomet 3i is recalling 92 units of 3I Osseotite dental implants because they were incorrectly packaged. The affected units were distributed in the US and several international countries.
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-only problem with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for cosmetic or packaging defects.
Plain-English summary
Biomet 3i, LLC is recalling 92 units of 3I Osseotite dental implants, model number IOSS411, lot number 2016031461. The recall was initiated because the product was incorrectly packaged.
The affected dental implants were distributed to the states of California and Florida in the United States, as well as to Colombia, France, Germany, Italy, and Spain. The products are sterile and require a prescription.
Consumers and healthcare providers who have these specific dental implants should contact Biomet 3i, LLC for further instructions on how to handle the recalled units.
The recalled product
- Product
- 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 92
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)
- Model No: IOSS411
- Lot No: 2016031461
- UDI: (01)00844868007098(17)210401(10)2016031461.
Distribution
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