TeDan Surgical Innovations recalls sterile 12mm distraction screws (DS-0022) with damaged packaging that could expose products to non-sterile conditions, risking patient infections. Affected lots 2017111301 and 2018031401 sold to surgeons.
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 12mm distraction screws that may have damaged packaging, potentially exposing them to non-sterile conditions. This risk could lead to infections for patients during surgery.
The packaging for these surgical screws may be damaged, which could expose the screws to non-sterile conditions. This increases the risk of infection for patients during surgery.
Surgeons who purchased the recalled screws (lot numbers 2017111301 and 2018031401) are most at risk. Patients undergoing surgery with these screws could face infection risks.
Check for lot numbers 2017111301 or 2018031401 on the packaging. The product is a sterile 12mm distraction screw sold in boxes of 5.
Look for lot numbers 2017111301 or 2018031401 on the packaging.
The manufacturer found that the packaging for these screws may be damaged, potentially exposing them to non-sterile conditions, which could lead to patient infections.
Using screws with damaged packaging could expose them to non-sterile conditions, increasing the risk of infection for patients during surgery.
Check the packaging for lot numbers 2017111301 or 2018031401. The product is a sterile 12mm distraction screw sold in boxes of 5.
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-1505-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-1505-2020 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.
