PHANTOM CS QUICK START 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 PHANTOM CS QUICK START DISTRACTION SCREWS (14 mm, sterile, 5 per box) used for spinal distraction procedures. The screws are being recalled because the product pouches lack proper seals, which compromises the sterile condition stated on the packaging. The recall affects 495 screws distributed across 99 boxes worldwide, including distribution throughout the United States and to Australia, Canada, France, Philippines, Taiwan, U.A.E., and the United Kingdom. The affected product has lot number 2018071601, product code DS-0024, and UDI number 00851797006481.
The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 495 screws (packaged into 99 boxes) - [5 screws per box] Lot/code info: Product Code: DS-0024 UDI Number: 00851797006481 Lot Number: 2018071601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.