The Recall Desk
HighFDA (Devices)·Z-1818-2016·Announced 2016-06-01

Biomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects

Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.

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 for theoretical hazards without confirmed illness.

Plain-English summary

Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including arthroscopes, due to a defect in the sterile barrier packaging. The recall involves specific part numbers 908518 and 908520, and lot numbers 675890, 579290, and 579300.

The issue is insufficient seal strength on the sterile barrier packaging. This defect could jeopardize the seal, compromising the sterile barrier and causing the product to become nonsterile. If a nonsterile product is used or implanted, it may lead to an infection.

The affected products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, The Netherlands, Japan, Korea, Malaysia, Mexico, and Peru. Healthcare providers and consumers should stop using these specific products and contact Biomet for further instructions.

The recalled product

Product
Various trauma and sports medicine instruments and implants. Arthroscope.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Instruments
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 908518 908520 Lot #'s 675890 579290 579300

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 →

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