FDA recall, , Moderate risk
Medicrea IB3D Universal Implant Inserter and PL Instruments Set
Medicrea IB3D Universal Implant Inserter and PL Instruments Set may have a handle that untreads, causing inability to rotate implant.
Summary by Recall Canary from the FDA notice
What happened
Medicrea International, based in Rillieux La Pape, France, recalled the Medicrea IB3D PL Instruments Set and the Medicrea IB3D Universal Implant Inserter due to complaints that the orthopedic rotation tool handle may untread from the shaft, resulting in the inability to rotate the implant. The company began the recall on October 29, 2025, and the FDA added it to its Enforcement Report on January 9, 2026. The products were distributed in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
2 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- UDI-DI
- 03613720286677
- Lot code
- 21J0410
- 21J0414
- 21J0418
- 25A0023
- 21J0466
- 21J1027
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- Lot code
- 0001
- 0002
- 0003
- 0004
- 0005
- 0006
- 0008
- 0009
- 0010
- 0011
- 0012
- 0013
- 0014
- 0016
- 0017
- 0018
- 0020
- 0021
- 0024
- 0025
- 0026
- 0029
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Tennessee, California, Minnesota, North Carolina, Texas, Florida, Ohio, Rhode Island, Virginia.
- Company
- Medicrea InternationalRillieux La Pape, France
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97996
- Recall numbers
- Z-1038-2026 to Z-1039-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
