Medicrea Pass LP Trocar K-wire Recalled for Fit Issues
Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.
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 2/5 (Moderate).
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. The hazard is a mechanical fit issue where the wire does not enter the screw, which is a functional defect rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Medicrea International is recalling 30 units of the Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol (Product reference: A06010130). The recall is limited to lot number 18G0037, which was distributed nationwide.
The recall was initiated because the conical cannulated screws may not accept the 1.6mm K-wire. Specifically, the wire cannot enter the minimum tolerance axis threaded section of the screw.
No specific instructions for consumers or healthcare providers are provided in the source text regarding how to handle the recalled units.
The recalled product
- Product
- Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
- Manufacturer
- Medicrea International
- Hazard
- Affected units
- 30
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 (1)
- Lot number(s) : 18G0037
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Medicrea International 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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