TeDan Surgical Innovations recalls sterile 16mm distraction screws due to 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 16mm distraction screws because the packaging pouch seal may be missing. This could lead to contamination during surgery if the product isn't properly sealed.
The product is labeled as sterile but lacks a proper pouch seal. This means the screws could become contaminated during storage or handling, potentially causing infections during surgery if not properly sealed.
Surgical teams using the recalled screws for cervical spine procedures. Patients undergoing spinal surgery with this specific product are at risk of infection if the packaging is compromised.
Check for the product code DS-0026 and lot number 2018071601 on the packaging. The screws are sold in boxes of 5 and intended for cervical spine distraction procedures.
Inspect the pouch seal on the packaging for any missing or damaged seals.
The product is labeled as sterile but may have a missing pouch seal, which could lead to contamination. Do not use if the seal is compromised.
Look for product code DS-0026 and lot number 2018071601 on the packaging. The screws are sold in boxes of 5 for cervical spine procedures.
Inspect the pouch seal. If it's missing or damaged, do not use the product. Contact the manufacturer for further instructions.
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-2530-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2530-2020 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.
