Phantom CS Quick Start Distraction Screw recall
PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the…
Why was Phantom CS Quick Start Distraction Screw recalled?
Lack of pouch seal. Product is labelled as sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: DS-0026 UDI Number: 00851797006498 Lot Number: 2018071601
- Product
- PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the…
- Recalling firm
- TeDan Surgical Innovations LLC
- Quantity
- 340 screws (packaged into 68 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.
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)