DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE — Class II medical device recall Z-1505-2020
Terminated recall by TeDan Surgical Innovations LLC, reported 2020-03-25. The items identified for recall are labeled as sterile. However, the manufacturer has found that product packa
| Recall number | Z-1505-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TeDan Surgical Innovations LLC, Sugar Land, TX, United States |
| Recall initiated | 2019-02-18 |
| Classified | 2020-03-17 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-01-12 |
| Reason classes | labeling, sterility |
| Lot numbers | 2017111301, 2018031401 |
| Model numbers | DS-0022 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1505-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.