Recall Z-1503-2020— TeDan Surgical Innovations LLC
Class II · Terminated
Class II FDA medical device recall by TeDan Surgical Innovations LLC, initiated 2019-02-18, terminated 2021-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: D-0012 3COR 12MM 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: 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..
- Recalling firm
- TeDan Surgical Innovations LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-18
- Terminated
- 2021-01-12
- Firm location
- Sugar Land, TX, United States
Product description
D-0012 3COR 12MM 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.