Avitus Orthopaedics recalls bone harvesters with potential sterile pouch breaches that could compromise device sterility during surgery.
Breach in the sterile barrier pouch may compromise sterility of the device.
Avitus Orthopaedics recalls bone harvesters with a filter insert that may have a breach in the sterile pouch. This could compromise sterility during surgery, risking infection for patients.
The sterile barrier pouch may be compromised, allowing contamination of the device. This could lead to infection if the device is used during surgery without proper sterility.
Surgical patients and medical professionals using the Avitus Bone Harvester with filter insert for bone marrow harvesting. The risk is primarily for those undergoing procedures requiring sterile surgical instruments.
Check for the product name 'Avitus Bone Harvester w/ Filter Insert - 8mm' with catalog number BH-110. The lot numbers Z2458218A (exp. 2018-05-01), Z2458253B (exp. 2018-05-01), Z2458379B (exp. 2018-10-01), or Z2458448B (exp. 2019-01-01).
Verify the product name and catalog number to confirm if it is recalled.
The recall indicates a potential breach in the sterile pouch that could compromise sterility, so it is not recommended for use until the issue is resolved.
The recall does not specify a remedy, so contact Avitus Orthopaedics directly for guidance.
Check for the product name 'Avitus Bone Harvester w/ Filter Insert - 8mm' with catalog number BH-110 and the listed lot numbers.
We’ve drafted a message you can send Avitus to request your refund or repair — edit it as you like.
Subject: Recall Z-1046-2019 — Avitus Avitus Hello, I own a Avitus that is covered by recall Z-1046-2019 from Avitus. 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.
