Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead 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 for theoretical hazards without confirmed illness.
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, specifically smooth fixation pins. The recall is due to 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 the product becomes nonsterile and is used or implanted, it may lead to an infection. The affected 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.
Healthcare providers and consumers should stop using these products and contact Biomet, Inc. for further instructions. The recall includes specific part numbers and lot numbers listed in the official FDA record Z-1822-2016.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
- 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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