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Recall Observatory FDA recall evidence

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

March 11, 2021

Class II

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

    reason.no_named_rule · v1.0.0

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

Field note

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