CLASS II Device recall · Reported 11 Aug 2021 · FDA Enforcement Report
Straumann SCS Screwdriver, driver, for ratchet, short, L recalled
Straumann USA is recalling Straumann SCS Screwdriver, driver, for ratchet, short, L, stainless steel Article Number, distributed nationwide in the US. The recall was initiated on 27 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2198-2021
- FDA event ID
- 88282
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 May 2021
- FDA classified
- 3 Aug 2021
- Reported
- 11 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 27 May 2021 | Recall initiated by company | |
| 3 Aug 2021 | Classified by FDA | +68 days |
| 11 Aug 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Packaged lot number: EHG85 Lot Number engraved on part: CXV34
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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