FDA Device recall Z-2198-2021
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument
- FDA Device
- Class II
- terminated
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument by Straumann Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2198-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-27 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Reason
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
Identifiers
| code_info | Packaged lot number: EHG85 Lot Number engraved on part: CXV34 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2198-2021%22
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