MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise
MicroAire Surgical Instruments is recalling Steinmann Pins 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 potential loss of sterility in a surgical implant, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling Steinmann Pins, a medical device used in surgical procedures for bone fixation and reconstruction. The recall is due to a defect in the sterile barrier pouch packaging where a defective seal may compromise the sterility of the device.
The recall involves 15,786 total units of Steinmann Pins, which are packed in clear tubes with end caps and placed in sterile barrier pouches. The affected products are 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 Steinmann Pins and contact MicroAire Surgical Instruments for instructions on how to return the products. Patients who have already had these pins implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Steinmann Pin, 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 1636-509…
- Manufacturer
- MicroAire Surgical Instruments, LLC
- 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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