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Recall Observatory FDA recall evidence

Device product

Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.

Z-1291-2022

June 02, 2022

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 90216
Status
Ongoing
Classification
Class II
Quantity
35 units
Official record key
device-enforcement:Z-1291-2022

Official wording

Reason: The instrument is incorrectly color coded.

Code information: Lot #2039558, GTIN 00889797006552.

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The instrument is incorrectly color coded.