SCS Screwdriver (Straumann) – Incorrect Tip Configuration (2021)
Incorrect screwdriver profile may prevent proper medical instrument usage.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Brand
Straumann USA LLC
Lot Codes / Batch Numbers
Packaged lot number: EHG85 Lot Number engraved on part: CXV34
Products Sold
Packaged lot number: EHG85 Lot Number engraved on part: CXV34
Straumann USA LLC is recalling Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046. due to Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026