Class II — TeDan Surgical Innovations LLC
| Recalling firm | TEDAN SURGICAL INNOVATIONS, INC. |
|---|---|
| Registered facility | TEDAN SURGICAL INNOVATIONS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Lack of pouch seal. Product is labelled as sterile. |
| 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. |
| Quantity | 1935 screws (packaged into 387 boxes) - [5 screws per box] |
| Distribution | 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. |
| Initiated | 2020-05-15 |
| Classified | 2020-07-07 |
| Terminated | 2022-09-08 |
| Recall number | Z-2525-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TeDan Surgical Innovations LLC (Z-2525-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85830/
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