Medicrea International recalls GRANVIA-C cervical intervertebral fusion devices with potential packaging pinholes that could affect safety. Check product codes and lot numbers listed to determine if your device is affected.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Medicrea International is recalling GRANVIA-C cervical spinal fusion devices due to a potential pinhole in the packaging that could compromise the device's integrity. This issue may lead to improper implant function or failure during surgery.
The packaging may have a pinhole in either the inner or outer pouch, which could allow contaminants to enter the device or cause it to fail during surgery. This might lead to improper spinal fusion or complications requiring additional procedures.
Patients who have received GRANVIA-C cervical spinal fusion devices with the listed reference numbers or lot numbers are affected. Surgeons and medical staff using these devices during procedures are at higher risk if the packaging issue occurs.
Check if your GRANVIA-C device has reference numbers starting with A13111427, A13112567, A13113456, A13131516, or A13131789, along with the corresponding lot numbers and GTINs listed in the recall notice.
Verify your GRANVIA-C device's reference number and lot numbers against the list provided in the recall notice to confirm if it is affected.
Check if your device has reference numbers or lot numbers listed in the recall notice to determine if it is affected.
The recall notice does not specify a remedy, so contact Medicrea International directly for guidance.
Compare your device's reference number and lot numbers with the list provided in the recall notice.
We’ve drafted a message you can send Medicrea International to request your refund or repair — edit it as you like.
Subject: Recall Z-2459-2023 — Medicrea International Medicrea International Hello, I own a Medicrea International that is covered by recall Z-2459-2023 from Medicrea International. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
