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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION Hemi Stepped Tibial Wedge

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  Class 2 Device Recall LEGION Hemi Stepped Tibial Wedge see related information
Date Initiated by Firm January 18, 2016
Create Date February 17, 2016
Recall Status1 Open3, Classified
Recall Number Z-0816-2016
Recall Event ID 73164
510(K)Number K043440  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
Code Information 14KM16422
Recalling Firm/
Manufacturer
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
FDA Determined
Cause 2
Packaging change control
Action The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.
Quantity in Commerce 8 units
Distribution Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SMITH & NEPHEW, INC.
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