FDA Medical Device Recalls (openFDA)
Walter Lorenz Surgical, Inc.: 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.
- Recall number
- Z-0385-2012
- Recalling firm
- Walter Lorenz Surgical, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2012-01-11
- Terminated
- 2011-12-12
- Reason
- Lorenz Engineer discovered flex tube could break if bent too much.
- Root cause
- 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
- 34 pieces
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
- Lot, serial or model codes
- Lot # 968720
- 510(k) numbers
- ["K002083"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28