Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for cosmetic or packaging-only problems.
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 packing. This packaging defect could potentially compromise the sterility or integrity of the devices.
Healthcare professionals and consumers should stop using these specific dental implants and contact Biomet 3i, LLC for instructions on how to return the products or obtain replacements.
The recalled product
- Product
- Certain EP Twist Lock TM Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- 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: IMIT33
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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