{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184265", "product_res_number": "Z-0463-2021", "event_date_initiated": "2020-10-08", "event_date_created": "2020-11-17", "recall_status": "Terminated", "event_date_terminated": "2024-05-09", "res_event_number": "86657", "product_code": "OWI", "product_description": "MEDICREA LIGAPASS TENSION PULLEY HANDLE XS-\nintended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies\nRef : A08200200", "code_info": "Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601  Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964", "firm_fei_number": "1000432246", "recalling_firm": "Medicrea International", "address_1": "Vancia", "city": "Vancia Vancia Rillieux La Pape", "country": "France", "reason_for_recall": "Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,", "root_cause_description": "Device Design", "action": "Medicrea International issued Reportable voluntary Recall notification dated 10/5/20 to via e-mail to distributors and subsidiaries stating reason for recall, health risk and action to take:\n\nInstructions sent to US subsidiary :\n1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA\n2. Circulate this Field Safety Notice internally to all interested/affected parties.\n3. Inform MEDICREA if any of the subject devices have been distributed to other organisations.\na) Please provide contact details so that MEDICREA can inform the recipients appropriately.\nb) If you are a Distributor, note that you are responsible for notifying your affected customers.\n4. Please inform MEDICREA of any adverse events concerning the use of the subject devices\nPlease comply with any local laws or regulations concerning the notification of adverse events to your National Competent Authority.\n5. Complete the attached customer response form. It may be that you no longer have any\nphysical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete even if you no longer have any of the subject devices in your physical inventory.\nContact: Karine TROGNEUX MEDICREA INTERNATIONAL\nRegulatory Affairs Manager, Direct : +33(0)4.69.85.95.39\nStandard : +33 (0)4.72.01.87.87.\nFax - N +33 (0)04 72 01 87 88\nMail : ktrogneux@medicrea.com", "product_quantity": "17 units US; 8 units OUS Expanded: 1 US and 3 OUS", "distribution_pattern": "CA\nForeign:France, Belgium", "openfda": { "k_number": [ "K132287", "K133617", "K160698", "K143350", "K230565", "K172021", "K170730", "K132395", "K161265", "K143759", "K213659", "K133482", "K173506", "K173117", "K200097", "K200281", "K190289", "K110348", "K180728", "K160208", "K201240", "K190418", "K172206", "K181799", "K153348", "K211057", "K161332", "K172417", "K261374", "K161267", "K191217", "K163181", "K142053", "K171881", "K222097", "K253615", "K151740" ], "registration_number": [ "3003935342", "1836357", "1526534", "1226544", "3010120135", "3009756327", "3004024955", "3016438694", "1720929", "3018094310", "3004142400", "1643817", "3003120897", "3016050940", "3007675554", "3010041430", "3030412764", "2027467", "9611390", "3010120339", "3009973505", "3014252644", "3006846753", "3013055499", "3006217744", "3005497913", "1527105", "3006639944", "3005706667", "3006563559", "3003477135", "1000432246", "3011221483", "9616062", "3006128100", "2031966", "3006460162", "1833920", "3009959868", "3009973699", "3010462278", "3004893332", "3013378907", "3019878714", "3006791286", "3004638532", "3015941638", "1835251", "1000517406", "3010162973", "3010370880", "3043543260", "3010123206", "3012120772", "3009380063", "1722511", "3009144915", "1030489", "3010032903", "3004774118", "1221763", "3012447612", "3007353762", "3009973336", "3003761012" ], "fei_number": [ "3003935342", "3003128516", "3002807041", "3002980729", "1526534", "3010120135", "3008599177", "3002806773", "3004024955", "3016438694", "1720929", "3018094310", "3004142400", "1643817", "3003120897", "3016050940", "3007675554", "3010041430", "3030412764", "2027467", "3010120339", "3009973505", "3014252644", "1000477302", "1000115656", "3006846753", "3013055499", "3006217744", "3005497913", "3006639944", "3005706667", "3011764740", "3006563559", "3003477135", "1000432246", "1000069183", "3011221483", "3006128100", "3006460162", "3009959868", "3010462278", "3009973699", "3019878714", "3004893332", "3013378907", "3006791286", "3004638532", "3002807038", "3003064967", "1000517406", "3010370880", "3043543260", "1000143502", "3010123206", "3012120772", "3009380063", "3009144915", "3010032903", "1221763", "3012447612", "3007353762", "3000205591", "3003258310", "3009973336", "3003761012" ], "device_name": "Bone Fixation Cerclage, Sublaminar", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3010", "device_class": "2" } } ] }