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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION Posterior Stabilized OXINIUM Femoral Component

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  Class 2 Device Recall LEGION Posterior Stabilized OXINIUM Femoral Component see related information
Date Initiated by Firm May 19, 2021
Create Date June 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-1951-2021
Recall Event ID 88010
510(K)Number K043440  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Code Information Lot 20HM17607
Recalling Firm/
Manufacturer
Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Mr. David Snyder
978-749-1440
Manufacturer Reason
for Recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form.
Quantity in Commerce 5 units
Distribution US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
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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