Implant Inserter Recall: Medicrea IB3D Universal
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677 |
|---|---|
| Lot / date codes | Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.