Recall Z-2527-2020— TeDan Surgical Innovations LLC
Class II · Terminated
Class II FDA medical device recall by TeDan Surgical Innovations LLC, initiated 2020-05-15, terminated 2022-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.. Reason: Lack of pouch seal. Product is labelled as sterile..
- Recalling firm
- TeDan Surgical Innovations LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-15
- Terminated
- 2022-09-08
- Firm location
- Sugar Land, TX, United States
Product description
PHANTOM CS DISTRACTION SCREW, 14 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.