Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Issues
Biomet 3i, LLC is recalling dental implant cover screws 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, and the hazard involves potential packaging failure (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 dental implant cover screws (items CS375, CS500, and CS600). The recall was initiated because the pouches containing these devices may not have been sealed during the packing process.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The specific distribution list includes Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay, and Viet Nam.
Consumers and healthcare providers should stop using the affected cover screws and contact Biomet 3i, LLC for further instructions or a replacement.
The recalled product
- Product
- Cover Screw 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 (2)
- Item: CS375
- CS500 and CS600.
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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