Oto Med recalls Grace Medical S-4500 SpineX Bone Dust Collectors with holes in sterile Tyvek pouches. These pouches may compromise sterility during surgery.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Oto Med is recalling Grace Medical S-4500 SpineX Bone Dust Collectors because internal testing found holes in the sterile Tyvek pouches. This could allow contamination during surgery, posing a risk to patients.
The sterile Tyvek pouches in these devices have holes found during internal testing. If the pouches are compromised, bone dust could become contaminated during surgery, potentially leading to infections.
Surgical teams using the Grace Medical S-4500 SpineX Bone Dust Collectors for otologic surgery are most at risk. The recall applies to specific lot numbers produced between 2019 and 2021.
Check for the Grace Medical S-4500 SpineX Bone Dust Collector with stainless steel filters. The product was sold with lot numbers 019120 G(2), 0712119 G(2), 0912118 G(2), and 1012119 G(2).
Look for the lot numbers 019120 G(2), 0712119 G(2), 0912118 G(2), or 1012119 G(2) on the device.
Internal testing found holes in the sterile Tyvek pouches of the devices, which could compromise sterility during surgery.
Check the lot number on the device. If it matches the recalled lots, contact Oto Med for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Oto Med to request your refund or repair — edit it as you like.
Subject: Recall Z-1521-2021 — Oto Med Oto Med Hello, I own a Oto Med that is covered by recall Z-1521-2021 from Oto Med. 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.
