Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling 1,648,273 dental implant devices 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 classified as FDA Class II, but the specific defect is a packaging issue (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a Low severity score (packaging-only problems).
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Implant EP Twist Lock TM Coping Dental implants. The recall was initiated because the pouches containing the devices may not have been sealed during the packing process.
The affected products include items with codes IIC46, IIC47, WIT56, WIT57, WIT55, WIT66, and WIT67. These 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 regarding the return or replacement of these devices.
The recalled product
- Product
- Implant EP Twist Lock TM Coping Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
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 (6)
- Items: IIC46
- IIC47
- WIT56
- WIT57
- WIT55
- WIT66 and WIT67
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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