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Recall Observatory FDA recall evidence

Device product

Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Z-0118-2021

September 21, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 86496
Status
Terminated
Classification
Class II
Quantity
47 devices
Official record key
device-enforcement:Z-0118-2021

Official wording

Reason: The anterior locking detail does not meet its design specifications.

Code information: Model: 71420966, Lot: 18JY09702

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The anterior locking detail does not meet its design specifications.