Medicrea Pass LP Blunt K-wire Recalled for Incompatibility with Screws
Medicrea International is recalling 190 units of Pass LP Blunt 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, but the source text describes a functional incompatibility defect without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Medicrea International is recalling 190 units of Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol (Product reference: A06010140). The recall affects lot numbers 18G0368, 19H0009, 18F0138, and 18G0038. The products were distributed nationwide.
The recall was initiated because the K-wires may not accept 1.6mm K-wires, preventing them from entering the minimum tolerance axis threaded section of Conical Cannulated Screws. This functional defect could interfere with the intended use of the medical devices.
Healthcare providers and facilities that have received these products should stop using them and contact the recalling firm for instructions on return or disposal. No specific instructions for individual consumers are provided in the source text, as these are professional medical devices.
The recalled product
- Product
- Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
- Manufacturer
- Medicrea International
- Affected units
- 190
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 (4)
- Lot number(s) : 18G0368
- 19H0009
- 18F0138
- 18G0038
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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