Agency classClass IIOur severity:High FDA (Devices)·Z-2528-2020·Announced 2020-07-15

TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

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 sterile medical device with a compromised seal, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

TeDan Surgical Innovations LLC is recalling 730 units of the Phantom CS Quick Start Distraction Screw, 12 mm, sterile, 5/box. The product is intended to be used for distraction in the anterior approach to the cervical spine.

The recall is being issued because the product lacks a pouch seal, despite being labeled as sterile. The affected units are identified by Product Code DS-0022, UDI Number 00851797006474, and Lot Number 2018062901.

The recalled 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. Users should stop using the product and contact the manufacturer for instructions.

The recalled product

Product: PHANTOM CS QUICK START 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 — Orthopedic / Spinal
Hazard: sterility-compromise
infection-risk

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)

Product Code: DS-0022 UDI Number: 00851797006474 Lot Number: 2018062901

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 3COR Distraction Screw Recall Due to Sterility Seal Failure
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