TeDan Surgical Innovations recalls 3COR Distraction Screws (12mm sterile, 5/box) due to lack of pouch seal, risking contamination. Affected units sold from 2017-2018. Contact for return.
Lack of pouch seal. Product is labelled as sterile.
TeDan Surgical Innovations is recalling 3COR Distraction Screws (12mm sterile, 5 per box) because the sterile pouch seal may be missing, risking contamination during surgery. This could lead to infections or other complications if the screws are used without proper sterility.
The screws are labeled as sterile but lack a secure pouch seal. This means the sterile packaging might be compromised during storage or handling, potentially allowing contamination before use in surgery.
Surgical professionals using these screws for cervical spine procedures are most at risk. Patients undergoing surgery with these screws could face infection if the seal is compromised.
Check for the product code D-0012 and UDI number 00843059121735. Units were sold from November 2017 to June 2018 with lot numbers 2017110901, 2018021501, or 2018061101.
Inspect the sterile pouch for a secure seal; if missing, do not use the screws.
The recall is due to a lack of pouch seal on the sterile packaging, which could lead to contamination during surgery.
Check the product seal; if missing, do not use the screws. Contact TeDan Surgical Innovations for further instructions.
Yes, affected units have lot numbers 2017110901, 2018021501, or 2018061101.
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-2524-2020 — TeDan Surgical Innovations TeDan Surgical Innovations Hello, I own a TeDan Surgical Innovations that is covered by recall Z-2524-2020 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.
