Medicrea Recalls Pedicle Screws Due to Incorrect Component Orientation
Medicrea International is recalling 3,529 pedicle screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw shank.
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: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device that could lead to disengagement during or after surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medicrea International is recalling 3,529 units of pedicle screws, available in multiple sizes and article numbers, due to a manufacturing defect. The recall covers screws manufactured in titanium alloy Ti-6Al-4V LI that are part of an internal fixation system.
The recall was initiated because an internal component was assembled in the incorrect orientation. This defect may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
The affected products were distributed worldwide, including nationwide distribution in the United States in the states of Colorado, Florida, Georgia, Louisiana, Ohio, and Rhode Island, as well as international distribution to Greece and Portugal. Healthcare providers and patients who have used these specific lots of pedicle screws should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B
- Manufacturer
- Medicrea International
- Affected units
- 3,529
Distribution
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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