{ "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": "160543", "product_res_number": "Z-0383-2018", "event_date_initiated": "2017-06-15", "event_date_created": "2018-01-17", "recall_status": "Terminated", "event_date_terminated": "2018-03-15", "res_event_number": "78802", "product_code": "KGN", "k_numbers": [ "K153690" ], "product_description": "PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.", "code_info": "Product Model Number\tProduct Lot Number\tProduct Description\tProduct Model Number\tProduct Lot Number\tProduct Description 607-004-880\t1508019\t8 x 8 cm\t607-005-014\t1702023\t14mm Disc 607-005-880\t1509051\t8 x 8 cm\t607-005-018\t1702024\t18mm Disc 607-005-440\t1512021\t4 x 4 cm\t607-005-220\t1702025\t2 x 2 cm 607-005-812\t1512022\t8 x 12 cm\t607-005-014\t1702026\t14mm Disc 607-005-440\t1603044\t4 x 4 cm\t607-005-018\t1702027\t18mm Disc 607-005-660\t1606038\t6 x 6 cm\t607-005-220\t1702028\t2 x 2 cm 607-001-112\t1611044\t10 x 12 cm\t607-005-014\t1702029\t14mm Disc 607-001-812\t1611045\t8 x12 cm\t607-005-018\t1702030\t18mm Disc 607-001-225\t1612013\t20 x 25 cm\t607-005-220\t1702031\t2 x 2 cm 607-001-009\t1612018\t0.2 x 26.5 cm\t607-005-014\t1702032\t14mm Disc 607-004-440\t1701034\t4 x 4 cm\t607-005-014\t1702033\t14mm Disc 607-001-440\t1701036\t4 x 4 cm\t607-005-014\t1702034\t14mm Disc 607-004-660\t1701037\t6 x 6 cm\t607-005-014\t1703007\t14mm Disc 607-001-660\t1701044\t6 x 6 cm\t607-005-018\t1703008\t18mm Disc   The affected lots are manufactured from February 2017 to May 2017.   The affected lots will expire in 2020 to 2021.", "firm_fei_number": "3004170064", "recalling_firm": "TEI Biosciences", "address_1": "7 Elkins St", "city": "Boston", "state": "MA", "postal_code": "02127-1601", "additional_info_contact": "617-268-1616", "reason_for_recall": "During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages:\n\" 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 \n\" 3 IFUs were missing pages 27 - 50 \n\" 1 IFU was missing pages 1 - 2 & 75 - 76\n\" 1 IFU was missing pages 15 - 62\n\nWhile pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.", "root_cause_description": "Error in labeling", "action": "Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017.", "product_quantity": "4081 units", "distribution_pattern": "U.S.", "openfda": { "k_number": [ "K260596", "K172010", "K200502", "K182838", "K143124", "K112409", "K896110", "K201577", "K181330", "K211902", "K233378", "K221520", "K253140", "K191992", "K935189", "K242146", "K913023", "K011026", "K200413", "K223257", "K914024", "K152033", "K050177", "K112191", "K122115", "K893647", "K002443", "K080010", "K122502", "K192725", "K955506", "K090894", "K153754", "K231152", "K092805", "K950281", "K152600", "K910944", "K090823", "K990086", "K000054", "K232796", "K901369", "K213498", "K080868", "K070269", "K252001", "K232758", "K060888", "K242828", "K072113", "K213598", "K172593", "K210128", "K212579", "K133290", "K231937", "K134037", "K241724", "K973170", "K253521", "K081782", "K083440", "K020732", "K061711", "K112888", "K153690", "K190528", "K021792", "K260532", "K260218", "K230980", "K994339", "K123756", "K082869", 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"3031238659" ], "device_name": "Wound Dressing With Animal-Derived Material(S)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ] }