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.
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 infection from nonsterile medical devices, which is a risk-of-harm product 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 reamers, due to a defect in the sterile barrier packaging. The recall is being conducted because the seal strength on the packaging is insufficient, which could jeopardize the seal and compromise the sterile barrier.
If the sterile barrier is compromised, the product could become nonsterile. If a nonsterile product 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.
The recall includes specific part numbers 41009, 110004188, and 110010579, as well as lot numbers 668490, 756990, 757010, 757030, and 758180. Healthcare providers and consumers should check their inventory for these specific part and lot numbers and stop using the affected products if they are found.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Reamer.
- 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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