The Recall Desk
HighFDA (Devices)·Z-2462-2016·Announced 2016-08-24

Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure leading to potential infection) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without confirmed harm.

Plain-English summary

Biomet 3i, LLC is recalling Drill Stop Dental implants because the pouches containing the devices may not have been sealed during the packing process. The recall affects 1,648,273 devices, including item codes DS2310, DS2315, DS2320, DS4513, DS4518, and DS458.

The unsealed pouches present a risk that the dental implants may not be sterile, which could lead to infection if used. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Healthcare providers and consumers should stop using these specific items and contact Biomet 3i for instructions on how to return or replace the affected devices.

The recalled product

Product
Drill Stop 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 (5)

  • Item: DS2310
  • DS2315
  • DS2320
  • DS4513
  • DS4518 and DS458

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

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Same hazard · sterility failure

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