Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.
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 1/5 (Low).
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 hazard is a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Biomet 3i, LLC is recalling Prep-tite Cap Dental implants. The recall involves 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands.
The recall was initiated because pouches containing the implants may not have been sealed during packing. The affected items include codes MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61, and WPFTC62.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- Prep-tite Cap 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)
- Item: MPFTC34
- MPTC32
- PFTC41
- PFTC42
- WPFTC51
- WPFTC52
- WPFTC61 and WPFTC62.
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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