DeRoyal recalls custom surgical procedure packs with non-sterile sternum saw blades marked by green sticker. These packs may cause infection if used in surgery.
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
DeRoyal is recalling custom surgical procedure packs that include sternum saw blades with non-sterile stickers. Using these packs during surgery could lead to infections due to unsterile blades.
The surgical saw blades in these packs have a green non-sterile sticker, meaning they are not properly sterilized. If used in surgery, this could lead to infections in patients.
Surgical teams using DeRoyal Open Heart Packs with specific reference numbers and lot numbers listed in the recall. Patients undergoing surgery with these packs are at risk of infection.
Check for Open Heart Packs with reference numbers a) 89-7483.07 through d) 89-7483.10. Look for green stickers on the sternum saw blades indicating non-sterile status.
Identify your Open Heart Pack by reference numbers and lot numbers listed in the recall notice.
The recall states the surgical saw blades have a green non-sterile sticker, indicating they were not properly sterilized.
The recall does not specify a remedy, so contact DeRoyal directly for guidance.
Yes, the recall lists specific lot numbers for each reference number (e.g., 48535952 for reference a).
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1139-2021 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1139-2021 from DeRoyal. 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.
