—#188276

Product

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

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Packaged lot number: EHG85 Lot Number engraved on part: CXV34

Why it was 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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Straumann USA LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2021-05-27
Terminated: 2023-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.