Arthrex, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1380-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 11, 2021

Date Posted: April 21, 2021

Recall Number: Z-1380-2021

Event ID: 87584

Reason for Recall:

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

Status: Terminated

Product Quantity: 32 units

Code Information:

Part number: AR-13200T-15.0; Lot code:12135408

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated