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 | This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch. |
| Product | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine. |
| Quantity | 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution |
| Distribution | Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan. |
| Initiated | 2012-06-11 |
| Classified | 2012-09-14 |
| Terminated | 2013-07-31 |
| Recall number | Z-2385-2012 |
| 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-2385-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62899/
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