Z-2093-2016Class II

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee...

Name: Z-2093-2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee...
Creator: Smith & Nephew, Inc.
Published: 2016-05-26
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-05-26 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2... on 2016-05-26. FDA classified it as Class II and gives the reason as "The surface inside of the femoral component, where cement is applied for adhesion, is below specification". 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-2093-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-26
Posted: 2016-06-29
Terminated: 2019-08-16
Recalling firm: Smith & Nephew, Inc.
Product: LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. 2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Contact Smith & Nephews Field Actions Department via email at [email protected] or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Indicate the RA number on your return shipment.
Quantity in commerce: 16 units
Distribution: Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
Product codes and lots: Lot codes: 15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2093-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2090-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2091-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2092-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2093-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2094-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29
Z-2095-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

Product code KRO

K081111Class IILegion Hinge Knee SystemSmith & Nephew, Inc. / cleared 2008-07-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)