Recall of Medicrea IMPIX MANTA+ spinal fusion devices with specific model numbers and lot codes due to potential packaging pinhole issues.
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 IMPIX MANTA+ spinal fusion devices (cervical) that have a potential pinhole in the packaging. This could lead to improper device handling or contamination during surgery. Affected units have specific model numbers and lot codes listed in the recall notice.
The packaging may have a pinhole that could allow contaminants to enter the device during surgery. This might lead to improper device handling or contamination, but the recall does not indicate a risk of serious injury in normal use.
Patients who have been prescribed the IMPIX MANTA+ spinal fusion device by their doctor and are using the affected model numbers and lot codes. Healthcare providers handling these devices are also at risk if they use the recalled units.
Check the product reference numbers (B20171743 through B20172273) and lot numbers listed in the recall notice. The devices are used for cervical spine fusion surgery.
Review the reference numbers and lot numbers provided in the recall notice to confirm if your device is affected.
The recall states there is a potential for a packaging pinhole, which could lead to contamination during surgery. However, the hazard is described as low risk and does not indicate a risk of serious injury in normal use.
Check the product reference numbers (B20171743 through B20172273) and lot numbers listed in the recall notice. The devices are used for cervical spine fusion surgery.
The recall does not specify a remedy, so you should check with your healthcare provider to determine if the device needs to be replaced or if further action is required.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2462-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2462-2023 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.
