Medicrea International recalls IMPIX MANTA lumbar intervertebral fusion devices with packaging pinholes that could cause contamination. Affected units include specific reference 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 International is recalling certain IMPIX MANTA lumbar spinal fusion devices due to a potential pinhole in the packaging that might lead to contamination. This recall affects specific product reference numbers and lot numbers listed in the notice.
The packaging may have a pinhole that could allow contaminants to enter the device during handling or use. This poses a risk of contamination, but the hazard is not described as causing serious injury or death in normal use.
Patients who have received the recalled IMPIX MANTA devices for spinal fusion surgery are most at risk. The recall applies to specific reference numbers and lot numbers listed in the notice.
Check the product reference numbers (a through m) and lot numbers listed in the recall notice. The IMPIX MANTA is a lumbar intervertebral fusion device used for spinal surgery.
Review the reference numbers and lot numbers provided in the recall notice to determine if your device is affected.
The recall states there is a potential for a packaging pinhole that could lead to contamination, but it does not describe a risk of serious injury or death in normal use.
Check the reference numbers (a through m) and lot numbers listed in the recall notice. The affected devices are specific to the listed reference numbers and lot numbers.
The recall does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2456-2023 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.
