Z-2524-2020 Class II Terminated
FDA device recall Z-2524-2020 was initiated by TeDan Surgical Innovations LLC on May 15, 2020 and is designated Class II. Reason for recall: Lack of pouch seal. Product is labelled as sterile. The recall status is terminated (terminated September 8, 2022). Affected quantity: 2735 individual screws (packaged into 547 boxes) - [5 screws per box].
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 15, 2020
- Termination Date
- September 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2735 individual screws (packaged into 547 boxes) - [5 screws per box]
Product Description
3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Reason for Recall
Lack of pouch seal. Product is labelled as sterile.
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.
Code Information
Product Code: D-0012 UDI Number: 00843059121735 Lot Number: 2017110901 2018021501 2018061101