TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.
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 involves a sterile medical device with a compromised seal, representing a risk of harm 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, 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 on the product, which is labeled as sterile.
The affected product is identified by Product Code DS-0014, UDI Number 00851797006450, and Lot Numbers 2018020801 and 2018061101. The recall covers 393 boxes containing 5 screws each. The products were distributed worldwide, including nationwide in the United States and in Australia, Canada, France, the Philippines, Taiwan, the U.A.E., and the United Kingdom.
The FDA has classified this recall as Class II. The source text does not report any specific illnesses or injuries associated with this defect. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- PHANTOM CS 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
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 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
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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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