OrthoPediatrics Recalls Trochar Scalpel Instruments for Design Defect
OrthoPediatrics Corp is recalling 78 trochar scalpel instruments that were not manufactured to design specifications and will not function as intended.
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, but the source text explicitly states no injuries or illnesses were reported, and the defect is a manufacturing deviation resulting in a non-functional device rather than a direct safety hazard like a sharp edge or toxic material.
Plain-English summary
OrthoPediatrics Corp is recalling 78 units of the Trochar Scalpel Instrument (Surgical Punch). The recall involves part number 01-1500-9014 and lot numbers 1466707 and 1466710. The devices were distributed nationwide, including in Alabama, Illinois, New York, Florida, Texas, Michigan, Kentucky, North Carolina, Colorado, and Georgia.
The recall was initiated after a sales representative reported that a replenishment instrument was too short. Investigation confirmed that the devices were not manufactured to design specifications and will not function as intended. The source text does not report any injuries or illnesses associated with the use of these devices.
Healthcare providers and facilities should stop using the affected trochar scalpel instruments and contact OrthoPediatrics Corp for instructions on return or replacement. Consumers are not directly affected as these are surgical instruments used by medical professionals.
The recalled product
- Product
- Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 78
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)
- Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710
Distribution
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