Howmedica recalls HRIS ACET CUP CUT TIP 32X140 surgical instruments due to potential sterility compromise from failed packaging tests. Affected units include specific lot numbers and part numbers for hip replacements.
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 their packaging may not have been sterile. This could lead to infections if the instruments are used without proper sterility.
The packaging for these surgical instruments failed sterility tests, meaning the instruments might not be sterile when opened. This could lead to infections during surgery if the instruments are used without proper sterilization.
Surgical teams and hospitals that use these specific hip replacement instruments. Patients undergoing hip surgery are at risk if the instruments are used without proper sterility.
Check for the part number 6210-5-200rker on the packaging. The instruments were sold with specific lot numbers listed in the recall notice, including X22H11A1 through X19D04.
Look for the part number 6210-5-200rker on the packaging of the instruments.
The packaging failed sterility tests, which could mean the instruments are not sterile when opened.
Check the packaging for the part number 6210-5-200rker and lot numbers listed in the recall notice.
Yes, if the instruments are used without proper sterility, patients could get infections during surgery.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1000-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1000-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
