FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medicrea IB3D PL Instruments Set recalled for rotation tool handle detachment risk
OTHERNationwide distribution
Stop using Medicrea IB3D PL Instruments Set
The handle on the orthopedic rotation tool in Medicrea's IB3D PL Instruments Set may become detached from the shaft during surgery, preventing proper rotation of the implant. This affects 44 units distributed across multiple U.S. states. No injuries have been reported.
- Stop using affected units immediately if your facility received them
- Contact Medicrea directly to report any issues or request replacement units
- Check your inventory against the affected lot numbers: 0001–0026 (see full list in original notice)
- Notify your surgical team and hospital procurement of this recall
Hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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 PL Instruments Set, Rx Only REF: SPS03174
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2026Don't want to check this manually?
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