TeDan Surgical Innovations recalls sterile distraction screws that may have damaged packaging, risking infection. Affected units were sold starting May 2018. Consumers should contact the company for details.
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
TeDan Surgical Innovations is recalling sterile distraction screws that may have damaged packaging, potentially exposing the product to non-sterile conditions. This could lead to infection risks for patients during surgery.
The packaging for the recalled screws may be damaged, allowing the screws to become non-sterile. This could lead to infections during surgical procedures if the screws are used without proper sterility.
Surgeons using the D-0014 3COR 14MM Distraction Screws for cervical spine procedures are affected. Patients undergoing surgery with these screws face the highest infection risk.
Check for the product name '3COR 14MM Distraction Screws, 5/Box, Sterile' with item number D-001: 2018050201. These were sold starting May 2018.
Reach out to TeDan Surgical Innovations for specific instructions on how to handle the recalled product.
The recall indicates potential packaging damage that could expose the screws to non-sterile conditions, increasing infection risk during surgery.
Look for the product name '3COR 14MM Distraction Screws, 5/Box, Sterile' with item number D-0014 2018050201, sold starting May 2018.
Contact TeDan Surgical Innovations directly for specific instructions on handling the recalled product.
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-1504-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-1504-2020 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.
