TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.
What this means for you
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 medical device labeled as sterile but lacking a seal, creating a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 1,965 units of the Phantom CS Distraction Screw, 12 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 labeling.
The affected product is identified by Product Code DS-0012, UDI Number 00851797006443, and Lot Numbers 2018021901 and 2018061101. The recall covers 393 boxes containing 5 screws each.
Distribution was worldwide, including the United States (AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA) and the countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom. Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- PHANTOM CS DISTRACTION SCREW, 12 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
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
Same manufacturer · TeDan Surgical Innovations LLC
See all →- HighTeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
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- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
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- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
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- HighTeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
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