FDA recall Z-1380-2021

Arthrex, Inc. · Class II · device

Product

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

Reason for recall

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

Distribution

Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.

Key facts

Status
Terminated
Initiation date
2021-03-11
Report date
2021-04-21
Termination date
2024-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1380-2021