Z-2198-2021 Class II Terminated
FDA device recall Z-2198-2021 was initiated by Straumann USA LLC on May 27, 2021 and is designated Class II. 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 The recall status is terminated (terminated March 21, 2023). Affected quantity: 130 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- May 27, 2021
- Termination Date
- March 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 pieces
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
Distribution Pattern
US Nationwide Distribution
Code Information
Packaged lot number: EHG85 Lot Number engraved on part: CXV34