FDAClass IIOctober 28, 2020

Genesis recall

Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of…

Why was Genesis recalled?

The anterior locking detail does not meet its design specifications.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: 71420966, Lot: 18JY09702

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…
Recalling firm
Smith & Nephew, Inc.
Quantity
47 devices
Distribution
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.
Recall date
October 28, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls