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.
Check against the official notice below — it lists the full affected range.
TeDan Surgical Innovations LLC is recalling 1,965 PHANTOM CS Distraction Screws (393 boxes containing 5 screws per box) intended for use in anterior cervical spine distraction procedures. The screws are labeled as sterile but have a lack of pouch seal, which compromises the sterility assurance of the product. The affected product has Product Code DS-0012, UDI Number 00851797006443, and Lot Numbers 2018021901 or 2018061101, and was distributed worldwide including throughout the United States and in Australia, Canada, France, Philippines, Taiwan, U.A.E., and the United Kingdom.
The recall was issued because the compromised pouch seal means the product cannot be guaranteed to remain sterile, posing a potential safety risk if used in surgical procedures. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of pouch seal. Product is labelled as sterile.
Reason for recall: Lack of pouch seal. Product is labelled as sterile. Distribution: 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. Quantity: 1965 screws (packaged into 393 boxes) - [5 screws per box] Lot/code info: Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.