FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medicrea IB3D Universal Implant Inserter recalled for handle detachment risk
What this means
Medicrea's IB3D Universal Implant Inserter tool handle may separate from the shaft during surgery, preventing the surgeon from rotating the implant as intended. The issue affects 44 units across multiple states. No injuries have been reported.
- Stop using affected devices immediately if you have one of the recalled lot numbers: 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, or 21J1027
- Contact Medicrea or your hospital supply department for instructions on device return or replacement
- Check with your surgical team if this device was used in a recent procedure
The agency's original wording
Hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Affected count
44 units
Manufactured in
5389 route de Strasbourg, Vancia, Rillieux La Pape, France
Products
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1038-2026Want us to check the next one for you?
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