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U.S. Department of Health and Human Services

Class 2 Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM

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  Class 2 Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM see related information
Date Initiated by Firm February 17, 2006
Date Posted January 11, 2012
Recall Status1 Terminated 3 on December 12, 2011
Recall Number Z-0384-2012
Recall Event ID 34843
510(K)Number K002083  
Product Classification Plate, bone - Product Code JEY
Product Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."

W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711.

Part # 80-3112-01 Lot 976580 Qty 41 10/18/2005.
Sold for use with:
Part # 80-3112-01 Lot # 976580 Qty 28.
Part # SP-1652 Lot # 048720 Qty 3.
Part #-1640 Lot # 056620 Qty 8.
Part # SP-1651 Lot # 056590 Qty 2.

Part # 80-3112-01 Lot 970060 Qty 31 10/20/2005.
Sold for use with:
Part # SP-1651 Lot # 056590 Qty 8.
Part # SP-1653 Lot # 056610 Qty 10.
Part # SP-1285 Lot # 056570 Qty 4.
Part # SP-1652 Lot # 056600 Qty 9.

Product Usage: Distraction devices are for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxiollofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb resorbable correction plates, which are implanted by fixation with LactoSorb bone screws.
Code Information Lot # 976580 and Lot # 970060
Recalling Firm/
Manufacturer		 Walter Lorenz Surgical, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
Manufacturer Reason
for Recall		 Lorenz Engineer discovered flex tube could break if bent too much.
FDA Determined
Cause 2		 Device Design
Action W. Lorenz Surgical notified consignees of recall by an Urgent Advisory Notice letter. Consignees were requested to acknowledge receipt of recall and provide product disposition. Initial letter was sent on March 2, 2006, March 15, 2006, follow-up letters sent on April 4, 2006 and May 15, 2006. For additional information call (904) 741-4400 or fax (904) 741-4500.
Quantity in Commerce 41 pieces and 31 pieces respectively
Distribution Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
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 = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.
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