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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

TeDan Surgical Innovations LLC: Lack of pouch seal. Product is labelled as sterile.

Agency Publication Date: July 10, 2020
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Affected Products

Product: PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Code: DS-0026 UDI Number: 00851797006498 Lot Number: 2018071601

Lot Numbers:
DS-0026
Number
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.

Product Code: D-0012 UDI Number: 00843059121735 Lot Number: 2017110901 2018021501 2018061101

Lot Numbers:
D-0012
Number
Product: 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Code: D-0014 UDI Number: 00843059121742 Lot Number: 2018020801 2018080601

Lot Numbers:
D-0014
Number
Product: PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Code: DS-0012 UDI Number: 00851797006443 Lot Number: 2018021901 2018061101

Lot Numbers:
DS-0012
Number
Product: PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101

Lot Numbers:
DS-0014
Number
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.

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

Lot Numbers:
DS-0022
Number
Product: PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

Product Code: DS-0024 UDI Number: 00851797006481 Lot Number: 2018071601

Lot Numbers:
DS-0024
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85830
Status: Resolved
Manufacturer: TeDan Surgical Innovations LLC
Manufactured In: United States
Units Affected: 7 products (2735 individual screws (packaged into 547 boxes) - [5 screws per box]; 1935 screws (packaged into 387 boxes) - [5 screws per box]; 1965 screws (packaged into 393 boxes) - [5 screws per box]; 1965 screws (packaged into 393 boxes) - [5 screw per box]; 730 screws (packaged into 146 boxes) - [5 screws per box]; 495 screws (packaged into 99 boxes) - [5 screws per box]; 340 screws (packaged into 68 boxes) - [5 screws per box])

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.