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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION & JOURNEY

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  Class 2 Device Recall LEGION & JOURNEY see related information
Date Initiated by Firm April 19, 2022
Create Date May 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-1099-2022
Recall Event ID 90078
510(K)Number K112941  K111711  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
Code Information LEGION NARROW PS OXIN SZ 6N RT: Model Number: 71421276; Lot: 21JM17389; UDI: (01)0885558234259(17)310925(10)21JM17389 JRNY II BCS FEMORAL OXIN LT SZ 5: Model Number: 74022125; Lot: 21JM18618; UDI: (01)00885556170410(17)310926(10)21JM18618
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
6409 E Holmes Rd
Memphis TN 38141-8310
For Additional Information Contact David Snyder
901-396-2121
Manufacturer Reason
for Recall		 It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Initial consignees were notified via email and overnight mail on 04/19/2022. The consignees were instructed to inspect their inventory, return affected product, and complete the response form.
Quantity in Commerce 16 units
Distribution Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.
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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