Z-1418-2022Class II

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial...

Name: Z-1418-2022 (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial...
Creator: Smith & Nephew, Inc.
Published: 2022-06-27
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2022-06-27 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166 on 2022-06-27. FDA classified it as Class II and gives the reason as "The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks". 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-1418-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-27
Posted: 2022-07-20
Terminated: 2026-03-25
Recalling firm: Smith & Nephew, Inc.
Product: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 6/27/2022 via email and overnight mail on 6/27/2022. The letter described the issue, product details, shipment dates, potential risk of use of the product, and said that the required actions could be found on the attached response form. The response form was flagged that all items are to be completed and the form is to be returned within 5 days of receipt. The required actions instructed the consignee to inspect their inventory and quarantine the affected product. If the consignee is a sales rep, district office, or a distributor, they must notify their customers of the field action and ensure the required actions are complete. If there is no product to return, they are to check the appropriate box to indicate no product is being returned. If there is product to return, they are to complete the form and list the product part number, batches, and quantities they are returning. By signing the form, they are confirming their organization is aware of the field action and it has been communicated throughout the organization.
Quantity in commerce: 31 devices
Distribution: US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.
Product codes and lots: Product #71420186 - Lot #21DM14954S, exp. October 2030, UDI #03596010206350. Product #71420166 - Lot #21FM13870A, exp. October 2030, UDI #03596010206268.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1418-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1418-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code JWH

K951987Class IIGenesis II Total Knee SystemSmith & Nephew Richards, Inc. / cleared 1995-08-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)