TeDan Surgical Innovations recalls sterile 14mm distraction screws due to potential pouch seal failure. This could compromise sterility during surgery. Affected units sold in 2018 with specific lot numbers.
Lack of pouch seal. Product is labelled as sterile.
TeDan Surgical Innovations is recalling sterile 14mm distraction screws because the packaging pouch seal may not hold, risking contamination during surgery. This is serious for surgical procedures where sterility is critical.
The packaging pouch seal may fail, allowing non-sterile materials to enter the sterile surgical environment. Since the product is labeled as sterile, this could lead to infections or other complications during surgery.
Surgical teams using these screws for cervical spine procedures. Patients undergoing surgery with this product are at risk of infection or complications due to potential contamination.
Check for the product name 'PHANTOM CS QUICK START DISTRACTION SCREW', 14mm, sterile, 5 per box. Affected units were sold with lot number 2018071601 in 2018.
Immediately stop using the recalled screws as they may not maintain sterility during surgery.
The packaging pouch seal may fail, risking contamination during surgery since the product is labeled as sterile.
Stop using it immediately as the recall requires discontinuation due to potential sterility risks.
The recall does not provide a fix; the remedy is to stop using the 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-2529-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2529-2020 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.
