Synthes recalls 13mm titanium hindfoot arthrodesis nails due to unconfirmed sterility. Products may cause infection if used in surgery without proper sterilization.
Products not sterilized, sterility cannot be confirmed
Synthes is recalling 13mm titanium hindfoot arthrodesis cannulated nails that may not be properly sterilized. Using these nails in surgery could lead to infections since sterility cannot be confirmed.
The nails were not properly sterilized during manufacturing, so they could introduce infections during surgery. This risk is specific to medical procedures where sterile instruments are required.
Surgical patients and healthcare providers who may have received these nails for foot/ankle procedures. Those with recent surgery using the recalled product are at highest risk.
Check for part number 04.008.378S or lot number 41P2222 on the packaging. The product is intended for tibiotalocalcaneal arthrodesis procedures to treat foot/ankle issues.
Look for part number 04.008.378S or lot number 41P2222 on the packaging.
The product was not properly sterilized during manufacturing, so sterility cannot be confirmed.
Using these nails in surgery could lead to infections since they may not be sterile.
Check for part number 04.008.378S or lot number 41P2222 on the packaging.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2024 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1234-2024 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.
