FDA recall Z-0143-2022

Smith & Nephew, Inc. · Class II · device

Product

6.5MMX165MM CANNULATED SCREW

Reason for recall

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Distribution

Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.

Key facts

Status
Terminated
Initiation date
2021-09-20
Report date
2021-10-27
Termination date
2023-03-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0143-2022