TeDan Surgical Innovations recalls sterile 12mm 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 12mm distraction screws because the packaging pouch may not seal properly. This could lead to contamination during surgical procedures if the product is not properly sterilized.
The pouch seal may not close properly, risking contamination of the sterile product. This could lead to infections or complications during surgery if the screw is not properly sterilized.
Surgical teams using these screws for cervical spine procedures are most at risk. Patients undergoing spinal surgery with this specific product are affected.
Check for the product code DS-0022 and lot number 2018062901 on the packaging. These screws were sold in 2018 for cervical spine procedures.
Inspect the pouch seal for proper closure before use. If the seal appears damaged or missing, do not use the product.
The pouch seal may not close properly, risking contamination of the sterile product during surgical procedures.
Check the packaging for the product code DS-0022 and lot number 2018062901. If you have the product, inspect the pouch seal before use.
The recall does not provide a specific fix. Users should inspect the pouch seal before use to ensure proper sterility.
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-2528-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2528-2020 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.
