Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Recall
- Recall Number
- Z-2198-2021
- Event Number
- 88282
- Firm
- Straumann USA LLC
- FEI Number
- 1000121052
- Product Code
- NDP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 27, 2021
- Terminated
- March 21, 2023
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
Description
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
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
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.
US Nationwide Distribution
130 pieces