{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "44814", "product_res_number": "Z-0385-2012", "event_date_initiated": "2006-02-17", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2011-12-12", "res_event_number": "34843", "product_code": "JEY", "k_numbers": [ "K002083" ], "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.\"\n\nW.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711. \n\nPart # SP-1328-01 Lot 968720 Qty 34 10/6/2005.\nSold for use with:\nPart # SP-1598-13 Lot # 041950 Qty 10. \nPart # SP-1597-13 Lot # 066720 Qty 9. \nPart # SP-1598-13 Lot 050140 Qty 15.\n\n\nProduct 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_info": "Lot # 968720", "firm_fei_number": "1032347", "recalling_firm": "Walter Lorenz Surgical, Inc.", "address_1": "1520 Tradeport Dr", "city": "Jacksonville", "state": "FL", "postal_code": "32218-2480", "reason_for_recall": "Lorenz Engineer discovered flex tube could break if bent too much.", "root_cause_description": "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.", "product_quantity": "34 pieces", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.", "openfda": { "k_number": [ "K943346", "K131289", "K884523", "K855030", "K943348", "K923705", "K020505", "K021341", "K121235", "K992330", "K163579", "K964649", "K003757", "K022035", "K021382", "K102656", "K092743", "K951392", "K000594", "K091807", "K062436", "K180962", "K983360", "K030989", "K003281", "K913688", "K021684", "K953806", "K082335", "K990140", "K170773", "K253206", "K980983", "K943071", "K033121", "K992158", "K862533", "K994060", "K033092", "K152326", "K171364", "K022844", "K932492", "K002207", "K022185", "K232889", "K010499", "K943347", "K233874", "K001219", "K030806", "K073307", "K040272", "K924138", "K132600", "K173039", "K953386", "K253373", "K910038", "K000836", "K220360", "K122647", "K202969", "K133304", "K141165", "K113251", "K972463", 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