Medicrea recalls PASS LP spinal fusion devices with specific REF numbers and lot numbers due to potential pinhole in packaging that could lead to product damage.
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 PASS LP spinal fusion devices that have a pinhole in the packaging. This issue could cause the device to become damaged, which might affect its proper function during surgery.
The packaging has a pinhole that could allow moisture or contaminants to enter the device. This might cause the device to become damaged or ineffective during spinal fusion surgery.
Patients who have received a PASS LP spinal fusion device with the listed REF numbers and lot numbers are affected. Surgeons and medical staff using these devices are at the highest risk.
Check the REF number on the device packaging. The affected models include PASS LP with REF numbers a) through k) as listed in the recall notice. Also check the lot numbers provided for each REF.
Look for the REF number and lot numbers listed in the recall notice to determine if your device is affected.
The recall is due to a potential pinhole in the packaging that could cause the device to become damaged, which might affect its function during spinal fusion surgery.
Check the REF number and lot numbers on your device packaging against the list provided in the recall notice.
Contact Medicrea directly to confirm if your device is affected and follow their instructions.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2458-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2458-2023 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.
