| Class 2 Device Recall LEGION Posterior Stabilized OXINIUM Femoral Component | |
Date Initiated by Firm | May 19, 2021 |
Create Date | June 24, 2021 |
Recall Status1 |
Terminated 3 on April 14, 2023 |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JWH
|
|
|
|