CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
D-0014 3cor Distraction Screws, 5/box, Sterile recalled
TeDan Surgical Innovations is recalling D-0014 3cor Distraction Screws, 5/box, Sterile. The recall was initiated on 18 Feb 2019 and the FDA has classified it as Class II.
Check your package
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-1504-2020
- FDA event ID
- 84252
- Recalling firm
- TeDan Surgical Innovations, Sugar Land, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Feb 2019
- FDA classified
- 17 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 18 Feb 2019 | Recall initiated by company | |
| 17 Mar 2020 | Classified by FDA | +393 days |
| 25 Mar 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
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
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
D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Where it was distributed
Worldwide.
Questions about this recall
Is D-0014 3cor Distraction Screws, 5/box, Sterile recalled?
Yes. TeDan Surgical Innovations recalled D-0014 3cor Distraction Screws, 5/box, Sterile on 18 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1504-2020.
Why was it recalled?
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
Which lots are affected?
Item #: D-0014 2018050201
Where was it sold?
Worldwide.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | 3cor Distraction Screw, Sterile, 5/box recalled | TeDan Surgical Innovations | Sterility | Nationwide |
| Device | CLASS II | Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled | TeDan Surgical Innovations | Sterility | Nationwide |
| Device | CLASS II | Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled | TeDan Surgical Innovations | Sterility | Nationwide |
| Device | CLASS II | Phantom Cs Distraction Screw, Sterile, 5/box recalled | TeDan Surgical Innovations | Sterility | Nationwide |
| Device | CLASS II | Phantom Cs Quick Start Distraction Screw, Sterile, 5/box recalled | TeDan Surgical Innovations | Sterility | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |