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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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