TeDan Surgical Innovations recalls 14mm sterile distraction screws for cervical spine procedures due to potential pouch seal failure. This could compromise sterility during surgery. Affected units sold with specific lot numbers.
Lack of pouch seal. Product is labelled as sterile.
TeDan Surgical Innovations is recalling 14mm sterile distraction screws used in cervical spine procedures because the sterile pouch seal might not stay closed. This could lead to contamination during surgery if the pouch opens.
The sterile pouch seal may not stay closed, which could allow contamination of the surgical site. Since the product is labeled sterile, any breach in the seal might compromise the infection control during surgery.
Surgical teams using these screws for cervical spine procedures are affected. Patients undergoing spinal surgery with this specific product are at risk of potential contamination.
Check for the product name '3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX' with lot numbers 2018020801 or 2018080601. These screws are used in cervical spine procedures.
Verify the product name and lot numbers to confirm if your screws are affected.
The sterile pouch seal may not stay closed, which could lead to contamination during surgery.
Check the product details and lot numbers to see if your screws are affected. If they are, contact the manufacturer for further instructions.
The recall is for potential contamination during surgery, not a risk of serious injury in normal use.
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-2525-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2525-2020 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.
