Biomet 3i Recalls Temporary Hexed Cylinder Dental Implants Due to Sealing Defects
Biomet 3i, LLC is recalling 1,648,273 Temporary Hexed Cylinder Dental implants because pouches may not have been sealed during packing.
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 is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard involves potential loss of sterility due to packaging defects, which is a significant risk for dental implants, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Temporary Hexed Cylinder Dental implants. The recall involves specific items identified by the codes IMMTCS1, IITCS41, IWTCS51, and IWTCS61. The agency has classified this as a Class II recall.
The recall was initiated because the pouches containing the implants may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the devices.
The affected devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions on how to handle these specific devices.
The recalled product
- Product
- Certain Temporary Hexed Cylinder Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 1,648,273
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)
- Items: IMMTCS1
- IITCS41
- IWTCS51 and IWTCS61.
Distribution
Part of a larger recall action
This product is one of 119 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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