Biomet Recalls Orthopedic Instruments Due to Sterile Packaging Seal Defect
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise 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 (infection from non-sterile 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, specifically orthopedic manual surgical instruments. The recall is due to insufficient seal strength on the sterile barrier packaging. This defect could jeopardize the seal, causing the sterile barrier to be compromised and the product to become nonsterile.
If the product becomes non-sterile and is used or implanted, it may lead to an infection. The affected products were distributed worldwide, including in the United States and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, The Netherlands, Japan, Korea, Malaysia, Mexico, and Peru. Specific part numbers and lot numbers are listed in the recall documentation.
Healthcare providers and consumers should stop using the affected products and contact Biomet, Inc. for further instructions on how to return or replace the items.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
- Manufacturer
- Biomet, Inc.
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.
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