FDA Medical Device Recalls (openFDA)
Straumann USA LLC: Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
- Recall number
- Z-2198-2021
- Recalling firm
- Straumann USA LLC
- Product
- Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
- Status
- Terminated
- Initiated
- 2021-05-27
- Posted
- not on file
- Terminated
- 2023-03-21
- 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
- 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 reg_complaint@straumann.com. 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
- 130 pieces
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Packaged lot number: EHG85 Lot Number engraved on part: CXV34
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDP
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28