Medicrea recalls IMPIX DLIF spinal fusion devices with pinhole packaging defects that could lead to injury during use. Affected units have specific reference numbers and lot codes.
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 IMPIX DLIF spinal fusion devices that may have pinholes in their packaging. This could potentially cause injury if the device is mishandled or damaged during use.
The packaging may have a pinhole that could allow contaminants to enter the device. This might cause infection or other complications if the device is not properly sealed during surgery or handling.
Patients who have received the IMPIX DLIF spinal fusion device with the listed reference numbers and lot codes are most at risk. Healthcare providers using these devices for surgery are also affected.
Check the reference numbers (B16123509 through B16165013) and lot numbers listed in the recall notice. The product is a spinal fusion device for lumbar intervertebral fusion.
Identify the reference number and lot number on your device to confirm if it is affected.
The packaging may have a pinhole in either the inner or outer pouch.
Check the reference numbers (B16123509 through B16165013) and lot numbers listed in the recall notice.
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-2455-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2455-2023 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.
