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.
FDA Recall Z-0385-2012 · Posted 2012-01-11
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Recalling FirmWalter Lorenz Surgical, Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2006-02-17
Date Terminated2011-12-12
Product Quantity34 pieces
Reason for Recall
Lorenz Engineer discovered flex tube could break if bent too much.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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