Implant Inserter Recall: Medicrea IB3D Universal
Announced 2026-01-21 · FDA
Medicrea International is recalling the Medicrea IB3D Universal Implant Inserter (Rx Only). The rotation tool handle may untread from the shaft, resulting in the inability to rotate the implant. The recall covers 44 units distributed nationwide in TN, CA, MN, NC, TX, FL, OH, RI, and VA, with Lot numbers 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, and 21J1027 (UDI: (01)03613720286677).
| Brand | Medicrea International |
|---|---|
| Product | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 |
| Reason | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. |
| Severity | moderate |
| Units affected | 44 |
| Distribution | US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. |
| Agency | FDA |
| Recall / campaign no. | Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677 |
WHAT YOU SHOULD DO
- Stop using any affected device and consult your surgeon or the facility where it was used.
- Contact the hospital or surgical center for guidance on inspection, procedures, or replacement.
- For questions, contact Medicrea or the FDA for recall information.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.