Skip to content

Product is 40mm Flexible Tube. ***NON-STERILE… recallZ-0383-2012 · Walter Lorenz Surgical, Inc. · initiated Feb 17, 2006

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Walter Lorenz Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Lorenz Engineer discovered flex tube could break if bent too much.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0383-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 17, 2006
Posted by the FDA
Jan 11, 2012
Recalling firm
Walter Lorenz Surgical, Inc.
Quantity
76 pieces
Product code
JEY
FDA submissions
K002083
Distribution
Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.

Product description

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 (models, lots, serial numbers)

Lot # 052190

Other devices under the same FDA submission

3 devices cleared under K002083 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 34843).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page