Tibial Opening Wedge Osteotomy Plate recall
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…
Why was Tibial Opening Wedge Osteotomy Plate recalled?
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number: AR-13200T-15.0; Lot code:12135408
- 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…
- Recalling firm
- Arthrex, Inc.
- Quantity
- 32 units
- 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.
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)