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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS II TIBIAL DRILL GUIDE

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  Class 2 Device Recall GENESIS II TIBIAL DRILL GUIDE see related information
Date Initiated by Firm April 20, 2010
Date Posted June 24, 2010
Recall Status1 Terminated 3 on December 07, 2011
Recall Number Z-1900-2010
Recall Event ID 55673
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA

Drill guide used as manual surgical instrument during knee replacement surgeries.
Code Information Batch # 08JM07761 and 08JM07761A.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Dave Archer
901-399-5427
Manufacturer Reason
for Recall		 Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side
FDA Determined
Cause 2		 Process control
Action All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.
Quantity in Commerce 12 units
Distribution International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
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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