Biomet 3i Recalls Preformance Temporary Cylinder Dental Implants
Biomet 3i, LLC is recalling Preformance Temporary Cylinder 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 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 certain Preformance Temporary Cylinder Dental implants. The recall is due to a packaging defect where pouches may not have been sealed during the packing process.
The affected products include items with codes IMPFTC34, IMPFTC32, IPFTC41, IPFTC42, IWPFTC51, IWPFTC52, IWPFTC61, and IWPFTC62. A total of 1,648,273 devices are subject to this recall. The products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Certain Preformance Temporary Cylinder 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 (7)
- Items: IMPFTC34
- IMPFTC32
- IPFTC41
- IPFTC42
- IWPFTC51
- IWPFTC52
- IWPFTC61 and IWPFTC62.
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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