TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 1,935 units of the 3COR 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 labeling as sterile.
The affected 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. The specific lot numbers involved are 2018020801 and 2018080601.
Healthcare providers and patients should check their inventory for the specific product code D-0014 and UDI number 00843059121742. If the product is found, it should be quarantined and returned to the manufacturer for credit or replacement.
The recalled product
- Product
- 3COR 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 Lack of Pouch Seal
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- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
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