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Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION:… recallZ-0385-2012 · 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-0385-2012
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
34 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 35mm Flex 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 # SP-1328-01 Lot 968720 Qty 34 10/6/2005. Sold for use with: Part # SP-1598-13 Lot # 041950 Qty 10. Part # SP-1597-13 Lot # 066720 Qty 9. Part # SP-1598-13 Lot 050140 Qty 15. 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 # 968720

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

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