Medicrea Polyaxial Pedicle Screws Recalled Due to Incorrect Length
Medicrea International is recalling 210 polyaxial pedicle screws that are 50mm long instead of the labeled 45mm, posing a risk of nerve contact and postoperative pain.
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 involves a medical device defect that poses a risk of harm (nerve contact and postoperative pain) but does not report any actual injuries or fatalities, fitting the criteria for a High severity score.
Plain-English summary
Medicrea International is recalling 210 units of Medicrea Pass LP polyaxial pedicle screws, reference number B02217545. The affected screws are labeled as 45mm in length but have an actual length of 50mm. The product is non-sterile and made of Ti-6Al-4V ELI material.
The recall was initiated because pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. A screw that is longer than intended could come into contact with nerves, potentially causing postoperative pain. The affected lots are 19A0630, 19B0329, and 19C0734, with expiration dates in January and March 2029.
The product was distributed in the United States (New York, Colorado, Ohio, Arizona, Florida, Texas, and Pennsylvania) and internationally in France, Belgium, South Africa, China, Spain, and Portugal. Healthcare providers and patients should contact Medicrea International for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PAR
- Manufacturer
- Medicrea International
- Affected units
- 210
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 #/Expiration Date: 19A0630/January 03
- 2029 19B0329 /January 21th
- 2029 19C0734 /March 03
- 2029
Distribution
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