Synthes recalls sterile RIA tube assemblies (min 520mm) for bone surgery use due to unconfirmed sterility. Products may cause infection if used without proper sterilization.
Products not sterilized, sterility cannot be confirmed
Synthes is recalling sterile RIA tube assemblies (minimum 520mm length) for bone surgery procedures. The tubes may not be properly sterilized, which could lead to infections during surgery if used without confirmed sterility.
The tubes may not be properly sterilized, meaning they could introduce infections during surgery. This is a risk when used for procedures like bone grafts or treating infected bone tissue.
Adults and adolescents aged 12-21 who use these tubes for bone surgery procedures. Patients undergoing osteomyelitis treatment or bone graft surgeries are most at risk.
Look for the part number 314.746S and lot numbers H802995, H803000, H803020, or H830033. These tubes are intended for use in adults and adolescents aged 12-21 for bone surgery procedures.
Verify the part number (314.746S) and lot numbers (H802995, H803000, H803020, H830033) to confirm if your tube assembly is affected.
The tubes may not be properly sterilized, so sterility cannot be confirmed. This could lead to infections during surgery if used without proper sterilization.
These tubes are used for bone surgery procedures in adults and adolescents aged 12-21, including clearing the medullary canal for implants, harvesting bone marrow, and treating osteomyelitis.
Check for part number 314.746S and lot numbers H802995, H803000, H803020, or H830033. These tubes are intended for use in adults and adolescents aged 12-21.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1237-2024 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1237-2024 from Synthes. 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.
