The Recall Desk
ModerateFDA (Devices)·Z-2492-2016·Announced 2016-08-24

Biomet 3i Recalls Preformance Post Dental Implants Due to Sealing Defects

Biomet 3i is recalling Preformance Post Dental implants because pouches may not have been sealed during packing. The recall covers 1,648,273 devices distributed worldwide.

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, and the source text describes a packaging defect (unsealed pouches) without reporting any specific illnesses, injuries, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling certain Preformance Post Dental implants because the pouches containing the devices may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the implants.

The recall affects 1,648,273 devices, including items with codes IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664, and IWPFP666. These products were distributed nationwide in the United States, including Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign countries.

Healthcare professionals and consumers should stop using these specific dental implants and contact Biomet 3i for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Certain Preformance Post 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 (8)

  • Items: IMPFP34
  • IMPFP36
  • IMPFP354
  • IMPFP356
  • IPFP456
  • IWPFP554
  • IWPFP556
  • IWPFP664 and IWPFP666.

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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