Z-0118-2021Class II

Genesis (GII) -

Name: Z-0118-2021 Genesis (GII) -
Creator: Smith & Nephew, Inc.
Published: 2020-09-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2020-09-21 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2020-09-21. FDA classified it as Class II and gives the reason as "The anterior locking detail does not meet its design specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0118-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-21
Posted: 2020-10-16
Terminated: 2026-05-22
Recalling firm: Smith & Nephew, Inc.
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The anterior locking detail does not meet its design specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 9/21/20 the firm sent a letter to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 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.
Product codes and lots: Model: 71420966, Lot: 18JY09702

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-16

Product code JWH

K962137Class IIGenesis II Constrained SystemSmith & Nephew Richards, Inc. / cleared 1996-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)