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

3cor Distraction Screw, Sterile, 5/box recalled

TeDan Surgical Innovations is recalling 3cor 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: D-0014 UDI Number: 00843059121742 Lot Number: 2018020801 2018080601

Quantity recalled1935 screws (packaged into 387 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-2525-2020
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

3COR 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

Why was it recalled?

Lack of pouch seal. Product is labelled as sterile.

Which lots are affected?

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

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

Other products in this recall event

6 other products · FDA event 85830

This product is part of a recall event; the main page for the event is 3cor Distraction Screw, Sterile, 5/box recalled.

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

More recalls from TeDan Surgical Innovations

All 13

Reported	Class	Recall	Company	Reason	Where
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 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

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide