Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential sterility issue due to packaging defects, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 Twist Lock Coping Dental implants. The recall is due to a manufacturing defect where pouches may not have been sealed during packing. This defect could potentially compromise the sterility of the devices.
The affected items include codes IIIC46, IIIC47, IWIT55, IWIT56, and IWIT57. The products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and Virgin Islands) and numerous foreign countries.
Consumers and healthcare providers should contact Biomet 3i for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Certain Twist Lock TM Coping 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 (4)
- Items: IIIC46
- IIIC47
- IWIT55
- IWIT56 and IWIT57.
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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