Howmedica recalls HRIS ACET CUP CUT TIP 26X140 surgical instruments due to potential sterility compromise from failed seal integrity testing. Affected units include specific lot numbers and part numbers.
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
Howmedica is recalling certain hip surgery instruments because the packaging may not have been sterile. This could lead to infections if the instruments are used without proper sterility.
The instruments' packaging failed seal integrity testing, meaning the sterile barrier might be compromised. This could allow contamination and increase infection risk during surgery.
Surgical teams and hospitals that use these specific hip replacement instruments. Patients undergoing hip surgery are at risk if the instruments are not properly sterile.
Check for the part number 6210-5-100 and lot numbers listed in the recall notice. These instruments are used in hip arthroplasty procedures.
Verify the part number 6210-5-100 and lot numbers listed in the recall notice.
The packaging failed seal integrity testing, which could compromise product sterility during surgery.
Check the part number and lot numbers against the recall list; contact Howmedica for further instructions.
Yes, if the instruments are not sterile, it could lead to infections during hip surgery.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0999-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0999-2024 from Howmedica. 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.
