# FDA recall Z-2198-2021

> **Straumann USA LLC** · Class II · device recall initiated 2021-05-27.

## 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

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2198-2021
- **Recalling firm:** Straumann USA LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-27
- **Report date:** 2021-08-11
- **Termination date:** 2023-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2021

## Citation

> AI Analytics. FDA recall Z-2198-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2198-2021. Source: US FDA. Licensed CC0.

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