Medicrea recalls IMPIX TLIF spinal fusion devices with specific reference numbers due to potential pinhole packaging defects that could affect product integrity.
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 TLIF spinal fusion devices because their packaging may have a pinhole. This could lead to the device being compromised during use, though the risk is not severe enough to cause immediate harm.
The packaging may have a pinhole in either the inner or outer pouch, which could allow the device to become contaminated or damaged. This might affect the device's performance during spinal fusion surgery, but it does not pose an immediate risk of injury.
Patients who have received the recalled IMPIX TLIF spinal fusion devices with the listed reference numbers and lot codes are most at risk. Healthcare providers using these devices for spinal surgery should also check their inventory.
Check the reference numbers (e.g., B15130607S) and lot numbers (e.g., 19B0894) on the device packaging. The product is an intervertebral fusion device for lumbar spine surgery.
Look for reference numbers like B15130607S and lot numbers such as 19B0894 on the device packaging.
No, the recall does not require stopping use. The packaging issue is low risk and does not cause immediate harm.
Contact Medicrea International directly to confirm if your device is affected and to get further instructions.
The recall states there is a potential packaging issue, but it does not indicate a risk of injury or serious harm.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2457-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2457-2023 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.
