Z-0092-2018Class II

smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R...

Name: Z-0092-2018 smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R...
Creator: Smith & Nephew, Inc.
Published: 2017-09-14
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-09-14 / Terminated

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are... on 2017-09-14. FDA classified it as Class II and gives the reason as "The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0092-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-14
Posted: 2017-11-16
Terminated: 2020-08-21
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
FDA root cause: Mixed-up of materials/components
Action: Smith & Nephew sent an Urgent Medical Device Recall Notice letter dated September 14, 2017 to consignees via email. The letter identified the affected product, problem and actions to be taken. The consignees (distributors) were directed as follows: Required Actions: 1. Please inspect your inventory and locate any unused devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 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 batch numbers and quantities of each batch that you are returning in the appropriate boxes below. 4. Complete the remainders of the form sign and send to [email protected] or fax to 901-566-7975. 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.
Quantity in commerce: 10 units
Distribution: US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Product codes and lots: Lot Number 14GSM0440A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0092-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0092-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-16

Product code JWH

K041106Class IIRevision Knee SystemSmith & Nephew, Inc. / cleared 2004-07-01

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)