MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals
MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.
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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) for a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling Kirschner-Wire (K-Wire) products, which are smooth or threaded wires used for bone fracture fixation, reconstruction, or traction. The recall is due to a defect in the sterile barrier pouches that may compromise the sterility of the medical devices.
The recall involves 15,786 total units of Kirschner-Wires packed in clear tubes with end caps, which are then placed in sterile barrier pouches. The affected products were distributed nationwide in the United States and internationally to Australia, Ireland, Canada, the Netherlands, Sweden, Japan, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected Kirschner-Wires and contact MicroAire Surgical Instruments for instructions on how to return the products. Patients who have already received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109…
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- Affected units
- 15,786
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MicroAire Surgical Instruments, LLC 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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