TeDan Surgical recalls sterile 3COR 12mm distraction screws due to potential packaging damage that could expose products to non-sterile conditions, risking infection during surgery.
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 is recalling sterile 3COR 12mm distraction screws because damaged packaging might expose them to non-sterile conditions, increasing infection risk for patients during surgery.
The packaging for specific lots may be damaged, allowing non-sterile conditions to contaminate the screws. This contamination could lead to infections during surgical procedures if the screws are used without proper sterility.
Surgeons using the recalled 3COR Distraction Screws for cervical spine procedures are affected. Patients undergoing surgery with these screws face the highest infection risk.
Check for the lot number 2018011601 on the packaging of the D-0012 3COR 12mm Distraction Screws. The product is sold in boxes of 5 screws and labeled as sterile.
Inspect the packaging for signs of damage that might expose the screws to non-sterile conditions.
The manufacturer found that packaging for specific lots may be damaged, potentially exposing the product to non-sterile conditions, which could lead to infections during surgery.
The lot number for the recalled product is 2018011601.
Look for the lot number 2018011601 on the packaging of the D-0012 3COR 12mm Distraction Screws, which are sold in boxes of 5 sterile screws.
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-1503-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-1503-2020 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.
