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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 Recall
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL
see related information
Date Posted August 22, 2013
Recall Status1 Open
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, Tennessee 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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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