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Recall Observatory FDA recall evidence

Device product

Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

Z-0514-2020

October 03, 2019

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 84148
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-0514-2020

Official wording

Reason: Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

Code information: Lot Number: G6091225, Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)

Distribution pattern: Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)