TeDan Surgical recalls sterile 14mm distraction screws due to potential lack of pouch seal, which could compromise sterility during spinal surgery.
Lack of pouch seal. Product is labelled as sterile.
TeDan Surgical is recalling sterile 14mm distraction screws because the pouch seal might not be properly closed, risking contamination during spinal surgery. This could lead to infections or other complications if the product is used without a secure seal.
The product is labeled as sterile but lacks a secure pouch seal. This could allow contamination during handling or use, potentially leading to infections or other complications in spinal surgery.
Surgical teams using the TeDan Phantom CS Distraction Screw for cervical spine procedures are most at risk. Patients undergoing spinal surgery with this specific screw model may be affected.
Check for the product code DS-0014 and UDI number 00851797006450 on the packaging. The screws come in boxes of 5 and were manufactured on specific dates: 2018020801 and 2018061101.
Inspect the pouch seal to ensure it is properly closed before use.
The product is labeled as sterile but may have a lack of pouch seal, which could compromise sterility during surgery. Consult your surgeon about the specific risks.
Look for product code DS-0014 and UDI number 00851797006450 on the packaging. The screws come in boxes of 5 and were manufactured on dates starting with 2018020801 or 2018061101.
The recall does not specify a remedy, so contact TeDan Surgical directly for guidance on handling the product.
We’ve drafted a message you can send TeDan Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2527-2020 — TeDan Surgical TeDan Surgical Hello, I own a TeDan Surgical that is covered by recall Z-2527-2020 from TeDan Surgical. 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.
