Biomet recalls specific lots of Oxford Fixed Lateral devices due to potential sterile seal breaches that could compromise device sterility during surgery.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Biomet is recalling specific lots of Oxford Fixed Lateral devices because some may have a breach in the sterile packaging seal. This could lead to loss of sterility during medical procedures, posing a risk to patient safety.
The sterile packaging seal could be compromised, leading to loss of sterility. This means the device might not be safe for surgical use, potentially causing infections or complications.
Medical professionals who use these devices for orthopedic surgery are most at risk. Patients receiving these devices during surgery may be affected if the seal breach occurs.
Check for item numbers 154330, 154370, 154373, or 154376 on the device packaging. The recall affects specific lots: 197660, 207230, 085200, and 155720.
Look for item numbers 154330, 154370, 154373, or 154376 on the device packaging.
The recall is due to potential breaches in the sterile packaging seal that could lead to loss of sterility of the device.
Check the device packaging for item numbers 154330, 154370, 154373, or 154376. If you have these item numbers, contact Biomet for further instructions.
If the sterile seal is breached, the device may not be safe for surgical use, potentially causing infections or complications.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0624-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0624-2021 from Biomet. 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.
