Z-1105-2018Class II

smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The...

Name: Z-1105-2018 smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The...
Creator: Smith & Nephew, Inc.
Published: 2018-02-01
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-02-01 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for... on 2018-02-01. FDA classified it as Class II and gives the reason as "The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5". 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-1105-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Posted: 2018-03-19
Terminated: 2018-10-22
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are 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. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by email on February 1, 2018. The letter stated the following: "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. If you have any questions or concerns regarding this recall please contact [email protected]." For further questions, please call (901) 396-2121.
Quantity in commerce: 28 units
Distribution: Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO, and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway.
Product codes and lots: Batch Number14AAP6352A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1105-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1105-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-19

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)