Recall Z-2198-2021— Straumann USA LLC
Class II · Terminated
Class II FDA medical device recall by Straumann USA LLC, initiated 2021-05-27, terminated 2023-03-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.. 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.
- Recalling firm
- Straumann USA LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-27
- Terminated
- 2023-03-21
- Firm location
- Andover, MA, United States
Product description
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.