Z-1380-2021 Class II Terminated
FDA device recall Z-1380-2021 was initiated by Arthrex, Inc. on March 11, 2021 and is designated Class II. Reason for recall: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. The recall status is terminated (terminated October 29, 2024). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 11, 2021
- Termination Date
- October 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
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.
Reason for Recall
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
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.
Code Information
Part number: AR-13200T-15.0; Lot code:12135408