Arthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
Arthrex, Inc. is recalling 32 units of Tibial Opening Wedge Osteotomy Plates because five parts were incorrectly processed as a different model.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Arthrex, Inc. is recalling 32 units of the Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm (Part number: AR-13200T-15.0; Lot code: 12135408). The recall was initiated after it was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
The affected devices are used in the treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. The recall covers units distributed worldwide, including nationwide distribution in the United States in the states of GA, LA, CA, FL, OR, and TX, as well as in India, Russia, the Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
Healthcare providers and patients should contact Arthrex, Inc. for instructions on how to return the affected devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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.
- Manufacturer
- Arthrex, Inc.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part number: AR-13200T-15.0
- Lot code:12135408
Distribution
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