TeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise
TeDan Surgical Innovations 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-harm product (infection risk due to potential sterility compromise) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
TeDan Surgical Innovations LLC is recalling 199 boxes (995 individual screws) of D-0014 3COR 14MM Distraction Screws. The products are intended for use in anterior cervical spine distraction procedures from C2 through C7. The recall was initiated because the manufacturer identified that product packaging for the affected lots may be damaged.
The damaged packaging potentially exposed the products to non-sterile conditions, despite the items being labeled as sterile. This situation presents a risk of infection to patients who use the devices. The affected products were distributed worldwide.
Healthcare providers and facilities should stop using the recalled items and contact TeDan Surgical Innovations for further instructions on return or replacement. Patients who have already received these implants should contact their healthcare provider to discuss the potential risks.
The recalled product
- Product
- D-0014 3COR 14MM 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-0014 2018050201
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
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