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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION HEMI STEP TIBIAL WEDGE

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  Class 2 Device Recall LEGION HEMI STEP TIBIAL WEDGE see related information
Date Initiated by Firm January 15, 2018
Create Date September 12, 2019
Recall Status1 Completed
Recall Number Z-2538-2019
Recall Event ID 83596
510(K)Number K043440  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432

Product Usage: 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.
Code Information 13KSL0038C
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		 The affected products were inadvertently packaged with an incorrect screw component.
FDA Determined
Cause 2		 Process control
Action The firm sent an Urgent Medical Device Recall Notice letter dated January 15, 2018 to consignees via email. The letter identified the affected product, problem and actions to be taken. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. For questions or concerns regarding this recall contact FieldActions@smith-nephew.com.
Quantity in Commerce 12 units
Distribution Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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