TeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing an infection risk.
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 risk of infection from potentially non-sterile medical devices, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 49 boxes (245 individual screws) of D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE. The affected items are identified by Item # D-0012 and Lot # 2018011601. These products were distributed worldwide.
The recall was initiated because the manufacturer found that the product packaging for the listed lots may be damaged. This damage potentially exposed the products to non-sterile conditions, despite the items being labeled as sterile. The 3COR Distraction Screws are intended for use in the anterior approach to the cervical spine from C2 through C7 by trained surgeons.
This situation presents a risk of infection to patients. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by…
- 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)
- Item #: D-0012 Lot #: 2018011601
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · TeDan Surgical Innovations LLC
See all →- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15
- 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
- HighTeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighTeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
- HighTedan Surgical Innovations Recalls Sterile Distraction and XL Screws
FDA (Devices) · 2012-09-26
- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
FDA (Devices) · 2020-07-15