TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.
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 involves a sterile medical device with a compromised seal, creating a risk of infection or harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 340 units of the Phantom CS Quick Start Distraction Screw, 16 mm, sterile, 5/box. The recall is due to a lack of pouch seal on the product, which is labeled as sterile.
The affected product is intended for use in distraction during the anterior approach to the cervical spine. The recall covers 68 boxes containing 5 screws each. The product was distributed worldwide, including nationwide in the United States and in Australia, Canada, France, the Philippines, Taiwan, the U.A.E., and the United Kingdom.
Healthcare providers and consumers should stop using the affected product. The specific lot number is 2018071601, and the product code is DS-0026.
The recalled product
- 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 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-0026 UDI Number: 00851797006498 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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- HighTeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
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- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
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