PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Reported: July 15, 2020 Initiated: May 15, 2020 #Z-2529-2020
Product Description
PHANTOM CS QUICK START 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.
Details
- Recalling Firm
- TeDan Surgical Innovations LLC
- Units Affected
- 495 screws (packaged into 99 boxes) - [5 screws per box]
- Distribution
- 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.
- Location
- Sugar Land, TX
Frequently Asked Questions
What product was recalled? ▼
PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.. Recalled by TeDan Surgical Innovations LLC. Units affected: 495 screws (packaged into 99 boxes) - [5 screws per box].
Why was this product recalled? ▼
Lack of pouch seal. Product is labelled as sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2529-2020.
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