Z-2198-2021Class II

Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401...

Name: Z-2198-2021 Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401...
Creator: Straumann USA LLC
Published: 2021-05-27
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2021-05-27 / Terminated

FDA source

Straumann USA LLC began a recall of Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument on 2021-05-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2198-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-27
Posted: 2021-08-03
Terminated: 2023-03-21
Recalling firm: Straumann USA, LLC
Product: Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Product code: NDP Accessories, Implant, Dental, Endosseous
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
FDA root cause: Under Investigation by firm
Action: Straumann USA issued Urgent Medical Device Recall letter on 5/27/21 via 2nd day air via UPS with email confirmation of request. Letter states reason for recall , health risk and action to take: Action to be taken: 1. If the article 046.401 (lot EHG85) is still in your inventory, then stop use / distribution of the product immediately and quarantine / segregate physically. 2. If the article 046.401 (lot EHG85) is still in your inventory, return it to the attention of Meaghan Atwell for credit or replacement as indicated on the Customer Confirmation Form. 3. Complete and return the enclosed Customer Confirmation Form to FSCA ER21-0077, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 or email [email protected]. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.
Quantity in commerce: 130 pieces
Distribution: US Nationwide Distribution
Product codes and lots: Packaged lot number: EHG85 Lot Number engraved on part: CXV34

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2198-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-08-03

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)