Medicrea International recalls IMPIX C+ spinal fusion devices with pinhole packaging defects that could lead to improper use. Affected units include specific reference numbers and lot numbers listed in the recall notice.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Medicrea International is recalling IMPIX C+ spinal fusion devices due to a potential pinhole in the packaging. This defect might cause the device to be improperly used or damaged, which could affect surgical outcomes.
The packaging may have a pinhole that could allow the device to become improperly aligned or damaged during surgery. This might lead to complications such as improper spinal fusion or device failure.
Patients who have received the IMPIX C+ spinal fusion device from Medicrea International are likely affected. Surgeons and medical staff who use these devices during cervical spine fusion procedures are at the highest risk.
Check the reference numbers (B20240104 to B20240208) and lot numbers listed in the recall notice. The device is used for cervical spine fusion procedures and is sold under specific GTINs and lot numbers.
Review the reference numbers and lot numbers provided in the recall notice to confirm if your device is affected.
The recall is due to a potential pinhole in the packaging that could lead to improper device alignment or damage during surgery.
Check the reference numbers and lot numbers listed in the recall notice to determine if your device is affected. If it is, contact Medicrea International for further instructions.
The recall indicates a potential packaging issue that could affect surgical outcomes, but the official notice does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Medicrea International to request your refund or repair — edit it as you like.
Subject: Recall Z-2460-2023 — Medicrea International Medicrea International Hello, I own a Medicrea International that is covered by recall Z-2460-2023 from Medicrea International. 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.
