The Recall Desk
HighFDA (Devices)·Z-1826-2016·Announced 2016-06-01

Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects

Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.

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 (infection from nonsterile implants) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including spinal interlaminal fixation orthoses. The recall is due to insufficient seal strength on the sterile barrier packaging. This defect could jeopardize the seal, compromising the sterile barrier and rendering the product nonsterile.

If the nonsterile product is used or implanted, it may lead to an infection. The affected products are identified by Part # 904756 and Lot # 625590.

These products were distributed nationwide in the United States and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, The Netherlands, Japan, Korea, Malaysia, Mexico, and Peru. Users should stop using the affected products and contact Biomet for further instructions.

The recalled product

Product
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implants
Hazard

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 (1)

  • Part #'s 904756 Lot #'s 625590

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Biomet, Inc. 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 14 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · infection

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