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 | 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. |
| Product | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. |
| Quantity | Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401) |
| Distribution | Worldwide. |
| Initiated | 2019-02-18 |
| Classified | 2020-03-17 |
| Terminated | 2021-01-12 |
| Recall number | Z-1505-2020 |
| 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-1505-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84252/
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