PHANTOM CS QUICK START 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 PHANTOM CS QUICK START DISTRACTION SCREWS (12 mm, sterile, 5 per box) used for spinal distraction procedures. The recall affects 730 screws packaged in 146 boxes distributed worldwide, including across numerous U.S. states and countries such as Australia, Canada, France, Philippines, Taiwan, U.A.E., and the United Kingdom. The recalled product is identified by Product Code DS-0022, UDI Number 00851797006474, and Lot Number 2018062901.
The screws are being recalled because the sterile pouches lack proper seals, which compromises the sterility of the product. The recall notice does not specify any remedy or action that affected consumers should take.
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: 730 screws (packaged into 146 boxes) - [5 screws per box] Lot/code info: Product Code: DS-0022 UDI Number: 00851797006474 Lot Number: 2018062901
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.