Biomet 3i Recalls Preformance Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants 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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling Preformance 15 degrees pre-angled post dental implants. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.
The recall covers 1,648,273 devices. The affected items include codes MPAPF34, MPAPF36, PAPF454, PAPF456, PAPF554, PAPF556, and PAPF666. These products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries.
Healthcare professionals and consumers should stop using these specific dental implants and contact Biomet 3i, LLC for further instructions regarding the unsealed packaging.
The recalled product
- Product
- Preformance 15 degrees pre-angled post 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 (6)
- Item: MPAPF34
- MPAPF36
- PAPF454
- PAPF456
- PAPF554
- PAPF556 and PAPF666
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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