FDA recall Z-1567-2022

Wright Medical Technology, Inc. · Class II · device

Product

Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

Reason for recall

An incorrect sizing label was applied to the carton packaging.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.

Key facts

Status
Ongoing
Initiation date
2022-07-27
Report date
2022-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1567-2022