Recall Z-1506-2020— 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: DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended 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
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended 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.