Device product
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Z-2524-2020
Product summary
- Event
- Event 85830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2735 individual screws (packaged into 547 boxes) - [5 screws per box]
- Official record key
device-enforcement:Z-2524-2020
Official wording
Reason: Lack of pouch seal. Product is labelled as sterile.
Code information: Product Code: D-0012 UDI Number: 00843059121735 Lot Number: 2017110901 2018021501 2018061101
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.