FDA recall Z-2198-2021

Product

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

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2021-05-27

Report date

2021-08-11

Termination date

2023-03-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2021