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.
Z-1380-2021
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 87584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-1380-2021
Official wording
Reason: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
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.
Derived failure modes
-
Unknown
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.