Device product
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.
Z-2530-2020
Product summary
- Event
- Event 85830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 340 screws (packaged into 68 boxes) - [5 screws per box]
- Official record key
device-enforcement:Z-2530-2020
Official wording
Reason: Lack of pouch seal. Product is labelled as sterile.
Code information: Product Code: DS-0026 UDI Number: 00851797006498 Lot Number: 2018071601
Distribution pattern: 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.
Derived failure modes
-
Unknown
Lack of pouch seal. Product is labelled as sterile.