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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL

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  Class 2 Device Recall GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL see related information
Date Initiated by Firm July 08, 2013
Date Posted August 22, 2013
Recall Status1 Terminated 3 on August 19, 2019
Recall Number Z-1996-2013
Recall Event ID 65738
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490,

Product Usage:
Orthopedic
Code Information Lot Number 12LM03798
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Joe Metzger
978-749-1330
Manufacturer Reason
for Recall		 The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
FDA Determined
Cause 2		 Labeling mix-ups
Action Smith & Nephew sent an Urgent Recall Notification letter dated July 8, 2013 to all affected customers. Surgeons were notified by letter beginning on July 16, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, locate unused devices, quarantine immediately, and return affected product to the address provided in the notification. For questions email to FieldActions@smith-nephew.com.
Quantity in Commerce 9 units
Distribution International only: Germany, France, United Arab Emirates, and United Kingdom.
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.
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