PHANTOM CS DISTRACTION SCREW, 14 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 (14 MM, STERILE, 5/BOX) distributed worldwide, including across numerous U.S. states and several other countries. These screws are designed for use in spinal distraction procedures during anterior cervical spine surgery. The recall affects 393 boxes with Lot Numbers 2018020801 and 2018061101 and Product Code DS-0014.
The screws are being recalled because the sterile pouches lack proper sealing, which compromises the sterile status of the product despite the sterile labeling. The source document does not specify a remedy or recommended consumer action.
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 screw per box] Lot/code info: Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.