Medicrea International: Intervertebral Fusion Devices Recalled for Potential Sterile Packaging Defect

What You Should Do

1. Identify if you have been treated with any of the following spinal fusion devices: IMPIX 3D, IMPIX ALIF, IMPIX ALIF S/A, IMPIX DLIF, IMPIX MANTA, IMPIX TLIF, PASS LP, GRANVIA-C, IMPIX C+, IMPIX S, or IMPIX MANTA+.
2. Check your medical records or contact your surgeon's office to verify the specific Reference (REF) and Lot numbers of the device used in your procedure.
3. For IMPIX 3D (Recall Z-2452-2023), check for Reference numbers like B242C09122810 (Lot 20B0926) or B247C07062410 (Lot 18D0965) among many others listed in the official recall data.
4. For IMPIX MANTA (Recall Z-2456-2023), specifically check for Reference numbers such as A20150407 (Lot 18F0803) or B20181743 (Lot 19D0208).
5. If you are a healthcare provider, immediately stop using any affected products in your inventory and quarantine them to prevent surgical use.
6. Contact your healthcare provider if you have concerns about a past surgery or are experiencing unusual symptoms at the site of a spinal implant.
7. Contact Medicrea International or your local distributor, Vancia, for instructions on returning unused affected products.
8. For additional information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products