FDA recall Z-1035-2022

Arthrex, Inc. · Class II · device

Product

K-Wire, 1.35 mm x 170 mm

Reason for recall

Products do not meet length and diameter specifications.

Distribution

Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

Key facts

Status
Ongoing
Initiation date
2022-03-25
Report date
2022-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2022