Aesculap recalls CAIMAN surgical instruments due to potential insufficient sterilization in batch 823B. This may affect instruments used in general and gynecologic surgery. Contact for remedy details.
possibility of the sterility batch being insufficiently sterilized
Aesculap is recalling a specific surgical instrument (CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM) because there's a risk the sterility batch might not have been properly sterilized. This could lead to infection during surgery if the instrument is used without proper sterilization.
The hazard involves a potential failure in the sterilization process of the instrument batch. If the instrument isn't properly sterilized, it could introduce bacteria into the surgical site, leading to infection. This risk is specific to the sterility batch that was produced.
Surgical professionals who use the CAIMAN instrument in general or gynecologic procedures are likely affected. Patients undergoing surgery with this instrument may be at risk if the instrument wasn't properly sterilized.
Check for the model number CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM and reference PL731SU- on the instrument. The affected batch number is 823B.
Look for the model number CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM and reference PL731SU- on the instrument.
The recall states there's a possibility the sterility batch was insufficiently sterilized, so it may not be safe to use without proper verification.
Check for the model number CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM and reference PL731SU- on the instrument, and ensure it's from batch 823B.
The recall record does not specify a remedy, so contact Aesculap directly for further instructions.
We’ve drafted a message you can send Aescul: Aesculap Implant Systems LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-2497-2019 — Aescul: Aesculap Implant Systems LLC Aescul: Aesculap Implant Systems LLC Hello, I own a Aescul: Aesculap Implant Systems LLC that is covered by recall Z-2497-2019 from Aescul: Aesculap Implant Systems LLC. 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.
