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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insert

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 Class 2 Device Recall LEGION(R) CR XLPE HIGH LEXION Articular Insertsee related information
Date Initiated by FirmMarch 30, 2018
Create DateMay 22, 2018
Recall Status1 Terminated 3 on August 21, 2019
Recall NumberZ-1907-2018
Recall Event ID 79875
510(K)NumberK071071 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Productsmith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Code Information Batch Numbers: 08BM09288; 12EM05884 & 12EM07720
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 the inner packaging pouch being sealed together with the outer pouch.
FDA Determined
Cause 2		Packaging process control
ActionThe firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Quantity in Commerce47 units
DistributionUS, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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