Medicrea recalls specific IMPIX ALIF spinal fusion devices due to potential pinhole packaging defects that could affect safety. Affected units include model numbers B15111209 through B15111412 with listed lot numbers.
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 ALIF spinal fusion devices (model numbers B15111209 to B15111412) because of a potential pinhole in the packaging. This defect could lead to improper device handling or contamination during surgery, though the risk is not described as causing serious injury in normal use.
The packaging may have a pinhole that could allow contaminants to enter the device pouch during handling or storage. This might lead to improper device use or contamination during surgical procedures, but the recall does not specify a risk of serious injury in normal use.
Patients who received the recalled IMPIX ALIF spinal fusion devices (model numbers B15111209 to B15111412) with specific lot numbers are most at risk. Healthcare providers using these devices for spinal fusion procedures may also be affected.
Check if your IMPIX ALIF spinal fusion device has model numbers B15111209, B15111212, B15111409, or B15111412 with the listed lot numbers. The packaging may show a pinhole in either the inner or outer pouch.
Inspect the packaging for a pinhole in either the inner or outer pouch. If found, stop using the device immediately.
The recall states there is a potential for a pinhole in the packaging, which could lead to contamination during surgery, but it does not describe a risk of serious injury in normal use.
The affected model numbers are B15111209, B15111212, B15111409, and B15111412 with specific lot numbers listed in the recall notice.
The recall does not specify a return or disposal requirement; the remedy is null, so no action is required beyond checking the packaging for pinholes.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2453-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2453-2023 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.
