The Recall Desk
ModerateFDA (Devices)·Z-2436-2016·Announced 2016-08-24

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

Biomet 3i, LLC is recalling Preformance 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, and the hazard involves a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling Preformance Post Dental implants under FDA recall number Z-2436-2016. The recall involves 1,648,273 devices, including items MPFP34, MPFP36, PFP454, PFP456, WPFP554, WPFP556, and WPFP666.

The recall was initiated because pouches containing the implants may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the devices.

The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Healthcare providers and patients should contact Biomet 3i, LLC for further instructions on how to handle the recalled devices.

The recalled product

Product
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 (6)

  • Item: MPFP34
  • MPFP36
  • PFP454
  • PFP456
  • WPFP554
  • WPFP556 and WPFP666.

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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