United StatesMedicrea is recalling the IB3D Universal Implant Inserter (REF A24000000) and the IB3D PL Instruments Set (REF SPS03174); affected units include lots 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027 and multiple SPS03174 lot numbers/UDIs listed by the firm, distributed in Tennessee, California, Minnesota, North Carolina, Texas, Florida, Ohio, Rhode Island and Virginia. The recall was initiated after complaints that the orthopedic rotation tool handle may untread from the shaft, resulting in inability to rotate the implant.
What's being recalled
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Recalling firm: Medicrea International, Rillieux La Pape, France.
How to identify it
Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677 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
The hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)