Z-0385-2012

Product is 35mm Flex TubeNON-STERILE PRODUCTCAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON...

Name: Z-0385-2012 Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON...
Creator: Walter Lorenz Surgical, Inc.
Published: 2006-02-17
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2006-02-17 / Terminated / root cause: design

FDA source

Walter Lorenz Surgical, Inc. began a recall of 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... on 2006-02-17. The reason FDA records is "Lorenz Engineer discovered flex tube could break if bent too much". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0385-2012
Status: Terminated
Initiated: 2006-02-17
Posted: 2012-01-11
Terminated: 2011-12-12
Recalling firm: Biomet Microfixation
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.
Product code: JEY Plate, Bone
Reason for recall: Lorenz Engineer discovered flex tube could break if bent too much.
Root cause tag: design
FDA 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 in commerce: 34 pieces
Distribution: Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
Product codes and lots: Lot # 968720

Product code JEY

K002083Class IILorenz Resorbable Distractor SystemWalter Lorenz Surgical, Inc. / cleared 2001-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)