Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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-0383-2012
Recall Event ID 34843
510(K)Number K002083  
Product Classification Plate, bone - Product Code JEY
Product Product is 40mm 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 # 80-3111-01 Lot 052190 QTY 76 Pieces 10/18/2005.
Sold for use with:
Part # 80-3111-01 Lot 052190 Qty 14.
Part # SP-1651 Lot # 069330 Qty 10.
Part # SP-1639 Lot # 046230 Qty 4.
Part # SP-1598-13 Lot # 041960 Qty 10.
Part # SP-1329 Lot # 039700 Qty 10.
Part # SP-1331 Lot # 039720 Qty 12.
Part # SP-1330 Lot # 039710 Qty 11.
Part # SP-1633 Lot # 056630 Qty 5.

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 # 052190
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 76 pieces
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.
-
-