TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a sterile medical device with a compromised seal, posing a risk of infection without reported injuries.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 495 units of the Phantom CS Quick Start Distraction Screw, 14 mm, sterile, 5/box. The product is intended for distraction in the anterior approach to the cervical spine. The recall is due to a lack of pouch seal, which affects the product's sterile status.
The affected product is identified by Product Code DS-0024, UDI Number 00851797006481, and Lot Number 2018071601. The distribution was worldwide, including the United States and several international countries such as Australia, Canada, France, the Philippines, Taiwan, the U.A.E., and the United Kingdom.
Healthcare providers and facilities should stop using the affected product and contact TeDan Surgical Innovations LLC for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- 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.
- Manufacturer
- TeDan Surgical Innovations LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: DS-0024 UDI Number: 00851797006481 Lot Number: 2018071601
Distribution
Part of a larger recall action
This product is one of 7 recalled by TeDan Surgical Innovations LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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