CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled

TeDan Surgical Innovations is recalling Phantom Cs Quick Start Distraction Screw, Sterile, 5/box, distributed nationwide in the US. The recall was initiated on 15 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: DS-0024 UDI Number: 00851797006481 Lot Number: 2018071601

Quantity recalled495 screws (packaged into 99 boxes) - [5 screws per box]

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2529-2020
FDA event ID: 85830
Recalling firm: TeDan Surgical Innovations, Sugar Land, TX
Classification: Class II
Status: Terminated
Recall initiated: 15 May 2020
FDA classified: 7 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Spinal Implants

Timeline

15 May 2020	Recall initiated by company
7 Jul 2020	Classified by FDA	+53 days
15 Jul 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of pouch seal. Product is labelled as sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.

Nationwide Arizona California Florida Georgia Hawaii Illinois Massachusetts Michigan North Carolina New Hampshire New Jersey Nevada New York Pennsylvania Puerto Rico Tennessee Texas Washington

Questions about this recall

Is Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled?

Yes. TeDan Surgical Innovations recalled Phantom Cs Quick Start Distraction Screw, Sterile, 5/box on 15 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2529-2020.

Why was it recalled?

Lack of pouch seal. Product is labelled as sterile.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from TeDan Surgical Innovations

All 13

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020Device	CLASS II	3cor Distraction Screw, Sterile, 5/box recalled	TeDan Surgical Innovations	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled	TeDan Surgical Innovations	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Phantom Cs Distraction Screw, Sterile, 5/box recalled	TeDan Surgical Innovations	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled	TeDan Surgical Innovations	Sterility	Nationwide
15 Jul 2020Device	CLASS II	Phantom Cs Distraction Screw, Sterile, 5/box recalled	TeDan Surgical Innovations	Sterility	Nationwide

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