Agency classClass IIOur severity:High FDA (Devices)·Z-2524-2020·Announced 2020-07-15

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.

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. 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
Category: Medical Device — Surgical Instrument
Hazard: sterility-compromise
infection-risk

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

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 →

Same manufacturer · TeDan Surgical Innovations LLC

See all →

Moderate
TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
High
TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
FDA (Devices) · 2020-07-15
High
TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
High
TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
High
TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15

Same hazard · sterility compromise