TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, 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 is classified as FDA Class II. The hazard involves a sterile medical device with a compromised seal, which poses a risk of infection or harm during surgical use, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws, 12 mm, sterile, 5/box. The recall is due to a lack of pouch seal, which means the product is not properly sealed despite being labeled as sterile. The product is intended to be used for distraction in the anterior approach to the cervical spine.
The recall involves 2,735 individual screws packaged into 547 boxes. The affected product codes are D-0012, with UDI Number 00843059121735. The specific lot numbers affected are 2017110901, 2018021501, and 2018061101.
Distribution was worldwide, including nationwide distribution in the United States across states such as AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA. The product was also distributed in Australia, Canada, France, the Philippines, Taiwan, the U.A.E., and the United Kingdom. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the product if found.
The recalled product
- Product
- 3COR 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
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12