Biomet 3i Recalls EP Twist Lock Dental Implants Due to Sealing Defect
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
What this means for you
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 hazard is a packaging defect (unsealed pouches) which is a potential risk but does not involve a direct structural failure of the implant itself or reported injuries, fitting the Moderate criteria for low-risk contamination or precautionary issues.
Plain-English summary
Biomet 3i, LLC is recalling certain EP Twist Lock TM Coping Dental implants. The recall involves 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The reason for the recall is that pouches containing the implants may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the packaging.
Healthcare professionals and patients who have received these specific dental implants should contact their provider or Biomet 3i for further instructions on how to proceed.
The recalled product
- Product
- Certain EP 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 (1)
- Item: IMIT35
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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