Straumann SCS Screwdriver — Class II medical device recall Z-2198-2021
Terminated recall by Straumann USA LLC, reported 2021-08-11, distributed nationwide. Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not pr
| Recall number | Z-2198-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2021-05-27 |
| Classified | 2021-08-03 |
| Reported by FDA | 2021-08-11 |
| Terminated | 2023-03-21 |
| Distributed | Nationwide (US) |
| Quantity | 130 units |
| Lot numbers | EHG85 |
| Model numbers | CXV34 |
Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Reason for recall
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury
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-2198-2021. 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.