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U.S. Department of Health and Human Services

Class 2 Device Recall LEGION(R) FEM CONE IMPACTOR HEADS

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  Class 2 Device Recall LEGION(R) FEM CONE IMPACTOR HEADS see related information
Date Initiated by Firm May 30, 2017
Date Posted June 12, 2017
Recall Status1 Terminated 3 on December 10, 2021
Recall Number Z-2625-2017
Recall Event ID 77413
510(K)Number K162775  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product LEGION(R) TIB CONE IMPACTOR HEADS:
a) REF 71441972, ID 24MM
b) REF 71441971, ID 22MM
c) REF 71441973, ID 26MM
d) REF 71441974, ID 28MM
e) REF 71441975, ID 30MM
Code Information Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Dave Snyder
978-749-1440
Manufacturer Reason
for Recall		 The incorrect Loctite adhesive was used to assemble the impactor heads.
FDA Determined
Cause 2		 Process control
Action The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.
Quantity in Commerce 46 units
Distribution US distribution to TN
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 and Original Applicant = Smith & Nephew, Inc.
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