External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. The hazard—potential wire tip fracture retained in the patient—is a risk-of-harm scenario where injury has not yet been reported, per rubric criterion for High severity.
Plain-English summary
OrthoPediatrics Corp has recalled 640 units of the Orthex External Fixation Wire Sharp Bayonet (1.8 x 400 mm, Model K400-18BN) due to a manufacturing defect. A variance near the transition zone of the wire tip increases the risk that the tip may fracture during use.
The affected wire is used in orthopedic external fixation procedures. The product was distributed nationwide in the United States (Arizona, Alabama, California, Florida, Maryland, Missouri, North Carolina, New York, and Texas) and internationally to Australia. Lot numbers 239006-B and 238997-B are affected.
If a fractured wire tip breaks off during surgery and remains in the patient, surgical teams may need to attempt retrieval, which could delay the procedure and potentially cause soft tissue damage or increase healing time. Patients or healthcare providers who have received or used this product should contact OrthoPediatrics Corp or their healthcare provider for guidance.
The recalled product
- Product
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 640
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)
- UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Distribution
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