TeDan Surgical Innovations recalls sterile 12mm distraction screws due to lack of pouch seal, potentially compromising sterility. Affected units sold in 2018 with specific lot numbers.
Lack of pouch seal. Product is labelled as sterile.
TeDan Surgical Innovations is recalling sterile 12mm distraction screws because the pouch seal may be missing, risking contamination. This could lead to infections during surgery if the product isn't properly sterile.
The product is labeled as sterile but lacks a pouch seal, which could allow contamination. This risk is specific to surgical settings where sterility is critical for preventing infections.
Surgical teams and hospitals using the recalled distraction screws for cervical spine procedures. Patients undergoing surgery with these screws face the highest risk of infection.
Check for the product code DS-0012 and lot numbers 2018021901 or 2018061101. The screws were sold in boxes of 5 in 2018.
Verify the product code DS-0012 and lot numbers 2018021901 or 2018061101 to confirm if your screws are affected.
The product is labeled as sterile but lacks a pouch seal, which could allow contamination during surgical procedures.
Check the product code and lot numbers to see if your screws are affected. If they are, contact TeDan Surgical Innovations for guidance.
The lack of pouch seal could lead to contamination, increasing infection risk during surgery. However, this is a low-risk issue as the product is used in controlled surgical settings.
We’ve drafted a message you can send TeDan Surgical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-2526-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2526-2020 from TeDan Surgical Innovations. 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.
