Biomet recalls three lots of acetabular hip cups due to insufficient data after double gamma sterilization. These hip implants may fail prematurely, risking complications. Affected units have specific lot numbers and expiration dates.
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
Biomet is recalling three specific lots of hip replacement cups because they were sterilized twice, which the company says doesn't support their safety or shelf life. This could lead to the implants failing earlier than expected, causing health issues for users.
The hip cups were gamma sterilized twice, but there's not enough data to confirm they work safely or last long after one sterilization. This means the cups might fail sooner than intended, potentially causing complications during surgery or after implantation.
Patients who received one of the recalled hip cup models from Biomet between 2022 and 2023 are likely affected. Those with the specific lot numbers or expiration dates listed in the recall are at higher risk.
Check for the lot number (e.g., 710930, 649750, 433290) or expiration date (June 14, 2023, or June 12, 2023) on the product packaging. The product names include 'RingLoc Bi-Polar Hip System Acetabular Cup ArCom' with specific sizes.
Look for the lot number or expiration date on the packaging to confirm if your hip cup is affected.
Biomet states that the hip cups were gamma sterilized twice, but there isn't enough data to support their safety or shelf life after one sterilization.
The recall doesn't specify a remedy, so contact Biomet directly to discuss next steps.
Yes, affected units have lot numbers like 710930, 649750, or 433290, with expiration dates of June 14, 2023, or June 12, 2023.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0097-2021 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-0097-2021 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.
