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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 Componentsee related information
Date Initiated by FirmMay 19, 2021
Create DateJune 24, 2021
Recall Status1 Terminated 3 on April 14, 2023
Recall NumberZ-1951-2021
Recall Event ID 88010
510(K)NumberK043440 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductLEGION 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 ContactMr. 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
ActionOn 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 Commerce5 units
DistributionUS Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
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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