PHANTOM CS QUICK START DISTRACTION SCREW, 16 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 has recalled Phantom CS Quick Start Distraction Screws (16 mm, sterile, 5 per box) used for spinal distraction procedures. The recall affects 340 screws across 68 boxes distributed worldwide, including to numerous U.S. states and several other countries. The screws are being recalled because the product pouches lack proper seals, despite being labeled as sterile.
The affected product has Product Code DS-0026, UDI Number 00851797006498, and Lot Number 2018071601. The source document does not specify what actions affected consumers or healthcare facilities 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: 340 screws (packaged into 68 boxes) - [5 screws per box] Lot/code info: Product Code: DS-0026 UDI Number: 00851797006498 Lot Number: 2018071601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.