Biomet Recalls Trauma and Sports Medicine Implants 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 infection from non-sterile medical devices, which is a significant health hazard, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including plates and fixation devices. 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 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 check their inventory for the specific part and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to Biomet, Inc. or the distributor according to the company's instructions.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
- 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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