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Recall Observatory FDA recall evidence

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

May 15, 2020

Class II

Product summary

Firm
TeDan Surgical Innovations LLC
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

    reason.no_named_rule · v1.0.0

    Lack of pouch seal. Product is labelled as sterile.