Medicrea recalls IMPIX S spinal fusion devices with specific reference numbers due to potential pinhole in packaging pouches. Affected units may have packaging defects that could lead to product contamination.
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 specific IMPIX S spinal fusion devices that have a potential pinhole in the packaging pouch. This issue could lead to product contamination if the device is exposed to moisture or other contaminants.
The pinhole in the packaging pouch could allow moisture or contaminants to enter the device, potentially causing product contamination. This might affect the device's effectiveness or safety during spinal fusion procedures.
Patients who have received the recalled IMPIX S spinal fusion devices with the listed reference numbers and lot codes are affected. Patients using these devices for cervical spine fusion are most at risk.
Check the reference numbers listed: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, or B15334074S. Also look for the specific lot numbers associated with each reference number.
Verify the reference number on your IMPIX S device to see if it matches the recalled list: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, or B15334074S.
The recalled IMPIX S devices have a potential pinhole in either the inner or outer pouch of the packaging, which could allow moisture or contaminants to enter.
Check the reference number on your device against the list: B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, or B15334074S. Each reference number has specific lot numbers that may be affected.
The recall does not specify a remedy, so no action is required beyond checking if your device is on the list.
We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2023 — Medicrea Medicrea Hello, I own a Medicrea that is covered by recall Z-2461-2023 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.
