The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2448-2016·Announced 2016-08-24

Biomet 3i Recalls Temporary Hexed Cylinder Dental Implants

Biomet 3i, LLC is recalling Temporary Hexed Cylinder 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 2/5 (Moderate).

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 a packaging defect (unsealed pouches) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling Temporary Hexed Cylinder Dental implants (items MMTCS1, ITCS41, WTCS51, and WTCS61) because the pouches containing the devices may not have been sealed during packing. The recall affects 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The FDA has classified this as a Class II recall. The source text does not report any specific illnesses or injuries associated with the unsealed pouches. Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i, LLC for further instructions on how to return or replace the products.

The recalled product

Product
Temporary Hexed 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 (3)

  • Item: MMTCS1
  • ITCS41
  • WTCS51 and WTCS61.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 119 products in this recall →

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