TeDan Surgical Innovations recalls sterile surgical distraction screws (DS-0024) with damaged packaging that could expose products to non-sterile conditions, risking patient infections. Affected lots 2018022801 and 2018050801.
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
TeDan Surgical Innovations is recalling sterile surgical distraction screws that may have damaged packaging, potentially exposing them to non-sterile conditions. This could lead to patient infections if used without proper sterility.
The packaging for certain lots of these sterile surgical screws may be damaged, which could expose the screws to non-sterile conditions. This risk of contamination could lead to infections during surgical procedures if the screws are not properly sterile.
Trained surgeons who purchased the recalled surgical screws (model DS-0024, lots 2018022801 and 2018050801) are affected. Patients receiving surgery with these screws face the risk of infection.
Check for the model DS-0024 (14mm distraction screw, 5 per box) with lot numbers 2018022801 or 2018050801. The product is labeled as sterile and intended for use by trained surgeons.
Inspect the packaging for damage that might expose the screws to non-sterile conditions.
The manufacturer found that packaging for certain lots may be damaged, potentially exposing the product to non-sterile conditions, which could lead to patient infections.
The affected model is DS-0024 (14mm distraction screw, 5 per box) with lot numbers 2018022801 and 2018050801.
Check for the model DS-0024 with lot numbers 2018022801 or 2018050801 on the packaging.
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-1506-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-1506-2020 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.
