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Recall Observatory FDA recall evidence

Device product

K-Wire, 1.35 mm x 170 mm

Z-1035-2022

March 25, 2022

Class II

Product summary

Firm
Arthrex, Inc.
Event
Event 89984
Status
Terminated
Classification
Class II
Quantity
300 pieces
Official record key
device-enforcement:Z-1035-2022

Official wording

Reason: Products do not meet length and diameter specifications.

Code information: Part Number: AR-8610K-43, Batch 1298116640 UDI: 00888867197084

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products do not meet length and diameter specifications.