Agency classClass IIOur severity:High FDA (Devices)·Z-2198-2021·Announced 2021-08-11

Straumann SCS Screwdriver Recalled for Incorrect Tip Configuration

Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical tool that poses a risk of injury if it cannot function properly during use. No illnesses or injuries have been reported. The hazard is theoretical—the tool may fail to perform correctly—but no actual harm has occurred. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article Number 046.401), a dental surgical instrument used for ratchet-driven screw insertion during dental procedures.

The screwdriver tip does not have the correct configuration or profile, which means it cannot properly fit and engage with the opposing screw head. As a result, the tool may be unable to pick up or manipulate screws as intended during dental surgical procedures. This malfunction creates a potential risk of injury to dental professionals and patients during use.

The recalled units were distributed nationwide in the United States. The affected lot numbers are EHG85 (on packaging) and CXV34 (engraved on the instrument).

Dental professionals and facilities in possession of affected instruments should discontinue use immediately and contact Straumann USA LLC for further instructions regarding replacement or return.

The recalled product

Product: Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Manufacturer: Straumann USA LLC
Category: Medical Device — Dental surgical instrument
Hazard: tool-malfunction
improper-fit
injury-risk
Affected units: 130

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Packaged lot number: EHG85 Lot Number engraved on part: CXV34

Distribution

Distributed nationwide across the United States.

Same manufacturer · Straumann USA LLC

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