Synthes recalls 1.5mm drill bits with part number 310.15S due to unconfirmed sterility. These surgical accessories may cause infections if used without proper sterilization.
Products not sterilized, sterility cannot be confirmed
Synthes is recalling 1.5mm drill bits with part number : 310.15S because they weren't properly sterilized. Using these bits without confirmed sterility could lead to infections during surgery.
These drill bits were not sterilized properly, so their sterility cannot be confirmed. If used in surgery without verified sterility, they could cause infections.
Surgical professionals and hospitals that use these drill bits for orthopedic procedures. The risk is low because the hazard is related to sterility, not immediate injury.
Check for part number 310.15S on the drill bit. The lot number is 19P4364, and these were sold with UDI 10886982186034.
Verify if the drill bit has been sterilized using the part number 310.15S and lot number 19P4364.
No, these drill bits were not sterilized properly, so their sterility cannot be confirmed. They should not be used without verified sterility.
Look for part number 310.15S and lot number 19P4364 on the drill bit, which has UDI 10886982186034.
Check if the drill bit has been sterilized. If not, do not use it and contact Synthes for guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2024 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1235-2024 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.
