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 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 involves a risk-of-harm product (dental implants) where a packaging defect (unsealed pouches) could compromise sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 Twist Lock TM Coping Dental implants (Item: IWIT66) due to a packaging defect. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.
The affected devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The unsealed pouches present a risk that the dental implants may not be sterile, which could lead to infection if used in patients.
Healthcare professionals and patients who have received these specific dental implants should contact Biomet 3i, LLC for further instructions on how to proceed. Consumers should not use the recalled devices until they have received guidance from the manufacturer or their healthcare provider.
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 (1)
- Item: IWIT66.
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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