Medicrea recalls IMPIX ALIF S/A lumbar fusion devices with potential packaging pinholes. Affected units have specific lot numbers and GTIN. Contact for return instructions.
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 certain lumbar intervertebral fusion devices due to a possible pinhole in the packaging. This could lead to contamination or improper handling of the device during surgery.
A pinhole in the packaging could allow contaminants to enter the device or cause improper handling during surgery. This might lead to infection or surgical complications if the device is not properly sterilized.
Patients who received the IMPIX ALIF S/A lumbar fusion device with lot numbers 18I0824 or 19L0046 are affected. Surgeons and medical facilities using these devices are most at risk.
Check for the lot numbers 18I0824 or 19L0046 on the packaging. The product has a GTIN of 03613720264439 and is labeled as an intervertebral fusion device for the lumbar spine.
Inspect the inner or outer pouch for any pinholes in the packaging.
The recalled device is the IMPIX ALIF S/A lumbar intervertebral fusion device with reference number B15241415.
Lot numbers 18I0824 and 19L0046 are affected.
Check for the lot numbers 18I0824 or 19L0046 on the packaging. The product has a GTIN of 03613720264439.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2454-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2454-2023 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.
