Biomet recalls specific lots of cannulated screws for bone fixation due to potential packaging seal breaches that could compromise sterility. Affected items include 4.0/5.0mm and other sizes with item numbers 110009810-110009852.
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 cannulated screws used for bone fixation because the packaging may have been compromised, risking contamination. This could lead to infections or other complications if the devices are used without proper sterility.
The packaging seal could be breached, leading to loss of sterility. If the device is not sterile, it could cause infections or other complications during surgery.
Patients who received the recalled screw systems for bone fracture fixation are at risk. Medical professionals using these devices for surgical procedures may also be affected.
Check for item numbers 110009810, 110009821, 110009825, or 110009852. The product is used for fixing small bones and long bones in fractures, and was sold with specific lot numbers: 180720, 334220, 285750, 285760.
Verify if your device has item numbers 110009810, 110009821, 110009825, or 110009852.
The packaging seal may have been breached, risking loss of sterility and potential contamination during surgery.
Check the item numbers and lot numbers to confirm if your device is affected. If it is, contact Biomet for further instructions.
The recall addresses potential contamination risk, but serious injury is not explicitly stated as a direct hazard.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0617-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0617-2021 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.
