Medicrea Iliac Screws Recalled Due to Incorrect Component Orientation
Medicrea International is recalling 3,529 Iliac Screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the shank.
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 3/5 (High).
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 defect presents a risk of harm (component disengagement) during a surgical procedure, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medicrea International is recalling 3,529 Iliac Screws, manufactured in titanium alloy Ti-6Al-4V LI, due to a manufacturing defect. The affected screws are part of an internal fixation system and are identified by specific article numbers and lot codes listed in the recall documentation.
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 to the states of Colorado, Florida, Georgia, Louisiana, Ohio, and Rhode Island, as well as international distribution to Greece and Portugal. Healthcare providers and patients should contact Medicrea International for instructions on how to proceed with the recall.
The recalled product
- Product
- Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI…
- 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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