Biomet recalls specific lots of 6.5/8.0mm cannulated screw systems due to potential packaging seal breaches that could compromise sterility. Affected items may not be safe for fracture fixation procedures.
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 6.5/8.0mm cannulated screw systems used in bone fracture repairs. The recall is because some packages might have been compromised, risking infection or contamination during surgery.
The packaging seal could be breached, leading to loss of sterility in the medical devices. This might cause infections or contamination during surgery if the devices are used without proper sterility.
Surgical patients undergoing bone fracture repairs with these specific screw systems. Surgeons and medical facilities using the recalled lots are most at risk.
Check for item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099. The affected lots are 167600, 288790, 286450, 368030, 180660, 285790, 285800, 179940, 179960, 179980, 180020, 288880, 288890, 288750, 179750.
Verify if your device has any of the listed item numbers: 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099.
Reach out to Biomet directly to confirm if your specific lot number is affected and get guidance on next steps.
The packaging seal might be breached, which could lead to loss of sterility in the medical devices.
These screws are used for fracture fixation of small bones, small bone fragments, and long bones.
Check for item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099. Affected lots are 167600, 288790, 286450, 368030, 180660, 285790, 285800, 179940, 179960, 179980, 180020, 288880, 288890, 288750, 179750.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0618-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0618-2021 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.
