{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "181452", "product_res_number": "Z-2354-2020", "event_date_initiated": "2019-01-07", "event_date_created": "2020-06-11", "recall_status": "Open, Classified", "res_event_number": "85642", "product_code": "OVD", "k_numbers": [ "K133827" ], "product_description": "A LINK Z INTERVERTEBRAL BODY FUSION DEVICE\n\nProduct Description:\nA Link Z Ti Unitary Plate-Cage 32x21x15 7\nA Link Z Ti Unitary Plate-Cage 32x21x15 12\nA Link Z Ti Unitary Plate-Cage 32x21x15 16\nA Link Z Ti Unitary Plate-Cage 32x21x15 16\nA Link Z Ti Unitary Plate-Cage 32x21x15 16\nA Link Z Ti Unitary Plate-Cage 32x21x15 20\nA Link Z Ti Unitary Plate-Cage 32x21x15 20\nA Link Z Ti Unitary Plate-Cage 32x21x15 20\nA Link Z Ti Unitary Plate-Cage 32x21x17 12\nA Link Z Ti Unitary Plate-Cage 32x21x17 16\nA Link Z Ti Unitary Plate-Cage 32x21x17 20\nA Link Z Ti Unitary Plate-Cage 32x21x19 20\nA Link Z Ti Unitary Plate-Cage 32x24x15 7\nA Link Z Ti Unitary Plate-Cage 32x24x15 16\nA Link Z Ti Unitary Plate-Cage 36x26x15 12\nA Link Z Ti Unitary Plate-Cage 36x26x15 12\nA Link Z Ti Unitary Plate-Cage 36x26x15 16\nA Link Z Ti Unitary Plate-Cage 36x26x15 16\nA Link Z Ti Unitary Plate-Cage 36x26x15 16\nA Link Z Ti Unitary Plate-Cage 36x26x15 16\nA Link Z Ti Unitary Plate-Cage 36x26x15 20\nA Link Z Ti Unitary Plate-Cage 36x26x15 20\nA Link Z Ti Unitary Plate-Cage 36x26x15 20\nA Link Z Ti Unitary Open Interbody 32x24x12 7\nA Link Z Ti Unitary Open Interbody 32x24x12 12\nA Link Z Ti Unitary Open Interbody 32x24x16 7\nA Link Z Ti Unitary Open Interbody 32x24x16 12\n\nProduct Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.", "code_info": "Product\t\tProduct Description\t\t\t\t\t Lot Number \t\t\t\t\t\t\t\t Number 14-32211507\tA Link Z Ti Unitary Plate-Cage 32x21x15 7\t\t 1000638 14-32211512\tA Link Z Ti Unitary Plate-Cage 32x21x15 12 \t\t1000259 14-32211516\tA Link Z Ti Unitary Plate-Cage 32x21x15 16 \t\t1000260 14-32211516\tA Link Z Ti Unitary Plate-Cage 32x21x15 16 \t\t1000325 14-32211516\tA Link Z Ti Unitary Plate-Cage 32x21x15 16 \t\t1000529 14-32211520\tA Link Z Ti Unitary Plate-Cage 32x21x15 20 \t\t1000261 14-32211520\tA Link Z Ti Unitary Plate-Cage 32x21x15 20 \t\t1000469 14-32211520\tA Link Z Ti Unitary Plate-Cage 32x21x15 20 \t\t1000556 14-32211712\tA Link Z Ti Unitary Plate-Cage 32x21x17 12 \t\t1000262 14-32211716\tA Link Z Ti Unitary Plate-Cage 32x21x17 16 \t\t1000640 14-32211720\tA Link Z Ti Unitary Plate-Cage 32x21x17 20 \t\t1000641 14-32211920\tA Link Z Ti Unitary Plate-Cage 32x21x19 20 \t\t1000530 14-32241507\tA Link Z Ti Unitary Plate-Cage 32x24x15 7\t\t 1000211 14-32241516\tA Link Z Ti Unitary Plate-Cage 32x24x15 16 \t\t1000536 14-36261512\tA Link Z Ti Unitary Plate-Cage 36x26x15 12 \t\t1000282 14-36261512\tA Link Z Ti Unitary Plate-Cage 36x26x15 12 \t\t1000583 14-36261516\tA Link Z Ti Unitary Plate-Cage 36x26x15 16 \t\t1000232 14-36261516\tA Link Z Ti Unitary Plate-Cage 36x26x15 16 \t\t1000383 14-36261516\tA Link Z Ti Unitary Plate-Cage 36x26x15 16 \t\t1000479 14-36261516\tA Link Z Ti Unitary Plate-Cage 36x26x15 16 \t\t1000652 14-36261520\tA Link Z Ti Unitary Plate-Cage 36x26x15 20 \t\t1000233 14-36261520\tA Link Z Ti Unitary Plate-Cage 36x26x15 20 \t\t1000360 14-36261520\tA Link Z Ti Unitary Plate-Cage 36x26x15 20 \t\t1000584 15-32241207\tA Link Z Ti Unitary Open Interbody 32x24x12 7\t\t1000572 15-32241212\tA Link Z Ti Unitary Open Interbody 32x24x12 12\t 1000573 15-32241607\tA Link Z Ti Unitary Open Interbody 32x24x16 7\t\t1000576 15-32241612\tA Link Z Ti Unitary Open Interbody 32x24x16 12\t 1000577", "firm_fei_number": "3010866843", "recalling_firm": "Acuity Surgical Devices, LLC", "address_1": "8710 N Royal Ln", "city": "Irving", "state": "TX", "postal_code": "75063-2539", "additional_info_contact": "Charlie Forton\n817-228-4890", "reason_for_recall": "Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.", "root_cause_description": "Process control", "action": "On 12/14/2018, the firm notified its supplier via email requesting to visually review its inventory which determined that some screw holes were oval shaped.\n\nOn 7/23/2019, all inventory was quarantined as part of the removal and was scrapped from inventory.\n\nDue to the low risk to patients and low probability, the firm ownly initially begin removal of product from internal locations (main warehouse) for the purpose of inspection and if necessary, repair or destruction.\n\nRemoval Summary\nNo additional customer or distributor communication took place during the removal.", "product_quantity": "A total of 27 lots producing 178 units", "distribution_pattern": "US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. 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"3009504230", "3030412764", "3004719693", "3002287318", "3011187779", "3008773560", "3003110073", "3002806773", "1526439", "3005178931", "3009962553", "3003120897", "3010009693", "3000718490", "3010197224", "3002807040", "3000205591", "3015869492", "1000149660", "3005180920", "3010049501", "3000207350", "3016438694" ], "device_name": "Intervertebral Fusion Device With Integrated Fixation, Lumbar", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3080", "device_class": "2" } } ] }