Medicrea recalls IMPIX 3D spinal fusion devices with pinhole packaging defects that could cause product damage. Affected units include specific REF numbers and lot numbers listed in the recall notice.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Medicrea is recalling IMPIX 3D spinal fusion devices due to a potential pinhole in the packaging pouches. This issue could lead to product damage but does not pose a direct safety risk to users.
The recall addresses a potential pinhole in either the inner or outer pouch of the product packaging. This could cause the device to become damaged or compromised during handling or use, but it does not indicate a direct safety hazard to the user.
Patients who have received the IMPIX 3D spinal fusion device from Medicrea International are likely affected. Those with the specific REF numbers and lot numbers listed in the recall are most at risk.
Check for the REF numbers listed in the recall: B242C09122810 through B247C15063210, along with the corresponding lot numbers provided in the notice. The product is an intervertebral fusion device for lumbar spine procedures.
Review the REF number and lot numbers on your device to see if it matches the affected units listed in the recall notice.
No, the recall addresses a potential pinhole in the packaging that could cause product damage but does not pose a direct safety risk to users.
Check your device's REF number and lot numbers against the list provided in the recall notice, which includes specific REF numbers from B242C09122810 to B247C15063210.
The recall does not require immediate action; you only need to check if your device matches the affected units listed.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2452-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2452-2023 from Medicrea. 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.
