FDAFDA · Food and drugs·Recall number Z-2526-2020
PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Published July 15, 2020 · Recall initiated: May 15, 2020
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
Lack of pouch seal. Product is labelled as sterile.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- TeDan Surgical Innovations LLC
- Distributor
- Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.
- Lot
- Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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