FDAFDA · Food and drugs·Recall number Z-1504-2020
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Published March 25, 2020 · Recall initiated: February 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- TeDan Surgical Innovations LLC
- Distributor
- Worldwide.
- Lot
- Item #: D-0014 2018050201
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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