Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (medical implant) where the hazard (infection) is theoretical and no injuries or illnesses have been reported in the source text.
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including rods, fixation devices, intramedullary devices, and accessories. 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 potentially rendering the product nonsterile.
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. Specific part and lot numbers are listed in the recall documentation.
If the product becomes nonsterile and is used or implanted, it may lead to an infection. Users should stop using the affected products and contact Biomet, Inc. for further instructions or a return.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
- 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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