MicroAire K-Wires Recalled for Incorrect Product Labeling
MicroAire Surgical Instruments is recalling 362 K-Wires due to mislabeling that incorrectly identified them as dual trocar instead of single trocar.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding product description, which fits the criteria for moderate severity.
Plain-English summary
MicroAire Surgical Instruments, LLC is recalling 362 units of MicroAire K-Wires. The recall is due to mislabeling on the product labels for three specific lots. The labels incorrectly described the product as "dual trocar" when the correct description is "single trocar."
The affected products are distributed in the United States. The specific part numbers and lot numbers involved are 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856). The total quantity distributed to the field is 362 units.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for these specific part and lot numbers and stop using the affected products if found.
The recalled product
- Product
- MicroAire K-Wires
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Part Number
- Lot Number
- Quantity Distributed to Field 1600-9355NS
- 61005
- 56
- 1600-9625NS
- 60297
- 209
- 1604-162NS
- 62856
- 97.
Distribution
Distribution scope not specified by the agency.
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