Biomet recalls specific lots of RINGLOC ACETABULAR SYSTEM self-tapping bone screws due to potential packaging seal breach that could compromise sterility. Affected items include model numbers 103531-103535 and lots 259830-260160.
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 RINGLOC ACETABULAR SYSTEM self-tapping bone screws because the packaging seal might be broken, which could cause the surgical implants to lose sterility. This is a serious risk for patients undergoing hip or knee replacement surgery.
The packaging seal could be compromised, leading to loss of sterility in the surgical implants. If the screws are not sterile, they could cause infections or other complications during surgery.
Patients who received these specific lots of screws during hip or knee replacement surgery are most at risk. Medical professionals using these screws for surgical procedures may also be affected.
Check if your screws have model numbers 103531, 103533, 103534, or 103535. Look for lot numbers 259830 through 260160 on the packaging or documentation.
Review the model numbers and lot numbers on the packaging to confirm if your screws are affected.
The recall is due to potential breaches in the sterile packaging seal of specific lots of screws, which could lead to loss of sterility.
The official recall notice does not specify a remedy, so contact Biomet directly for guidance.
The recall indicates a potential risk of loss of sterility, so affected items should not be used without confirmation from Biomet.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0627-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0627-2021 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.
