Z-1504-2020 Class II Terminated
FDA device recall Z-1504-2020 was initiated by TeDan Surgical Innovations LLC on February 18, 2019 and is designated Class II. Reason for recall: The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non ste… The recall status is terminated (terminated January 12, 2021). Affected quantity: 199 boxes (995 individual screws).
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2020
- Initiation Date
- February 18, 2019
- Termination Date
- January 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 199 boxes (995 individual screws)
Product Description
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Reason for Recall
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Distribution Pattern
Worldwide.
Code Information
Item #: D-0014 2018050201