{ "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": "178235", "product_res_number": "Z-0775-2020", "event_date_initiated": "2019-11-04", "event_date_created": "2020-01-03", "recall_status": "Terminated", "event_date_terminated": "2021-05-21", "res_event_number": "84397", "product_code": "KWS", "k_numbers": [ "K170910" ], "product_description": "Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.", "code_info": "GTIN 07630040712613 REF #\tLot 04.01.23\t184523 04.01.23\t184523 04.01.23\t184523 04.01.23\t184523 04.01.23\t184523 04.01.23\t184523 04.01.24\t184524 04.01.24\t184524 04.01.24\t184524 04.01.25\t184525 04.01.25\t184525 04.01.25\t184525 04.01.26\t184526 04.01.26\t184526 04.01.26\t184526 04.01.27\t184527 04.01.27\t184527 04.01.27\t184527 04.01.27\t1901138 04.01.27\t1901138 04.01.27\t1901138 04.01.27\t1901138 04.01.28\t184528 04.01.28\t184528 04.01.28\t1901139 04.01.29\t184529 04.01.29\t184529 04.01.29\t184529 04.01.29\t184529 04.01.29\t184529 04.01.29\t184529 04.01.30\t184530 04.01.30\t184530 04.01.31\t184531 04.01.31\t184531 04.01.31\t184531 04.01.31\t184531 04.01.31\t184531 04.01.32\t184532 04.01.33\t184533 04.01.33\t184533 04.01.33\t184533 04.01.33\t184533 04.01.33\t184533 04.01.33\t184533 04.01.34\t184534 04.01.34\t184534 04.01.34\t184534 04.01.34\t184534 04.01.35\t184535 04.01.35\t184535 04.01.35\t184535 04.01.35\t184535 04.01.35\t184535 04.01.35\t184535 04.01.35\t184535 04.01.36\t184536 04.01.36\t184536 04.01.36\t184536 04.01.36\t184536 04.01.36\t184536 04.01.36\t184536 04.01.36\t184536 04.01.37\t184537 04.01.37\t184537 04.01.37\t184537 04.01.37\t184537 04.01.37\t184537 04.01.37\t184537 04.01.37\t184537 04.01.38\t184538 04.01.38\t184538 04.01.38\t184538 04.01.38\t184538 04.01.38\t184538 04.01.39\t184539 04.01.39\t184539 04.01.39\t184539 04.01.39\t184539 04.01.39\t184539 04.01.39\t184539 04.01.40\t184540 04.01.40\t184540 04.01.41\t184541 04.01.41\t184541 04.01.41\t184541 04.01.41\t184541 04.01.41\t184541 04.01.41\t184541 04.01.43\t184543 04.01.43\t184543 04.01.43\t184543 04.01.44\t184544 04.01.44\t184544 04.01.44\t184544 04.01.45\t184545 04.01.45\t184545 04.01.45\t184545 04.01.45\t184545 04.01.45\t184545 04.01.45\t184545 04.01.46\t184546 04.01.46\t184546 04.01.46\t184546 04.01.47\t184547 04.01.47\t184547 04.01.48\t184548 04.01.48\t184548 04.01.49\t184549 04.01.49\t184549 04.01.50\t184550 04.01.50\t184550 04.01.52\t184552 04.01.53\t184553 04.01.53\t184553 04.01.53\t184553 04.01.54\t184554 04.01.54\t184554 04.01.54\t184554 04.01.55\t184555 04.01.55\t184555", "firm_fei_number": "3006639916", "recalling_firm": "Medacta Usa Inc", "address_1": "3973 Delp St", "city": "Memphis", "state": "TN", "postal_code": "38118-6110", "additional_info_contact": "Customer Service \n312-878-2381", "reason_for_recall": "Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.", "root_cause_description": "Device Design", "action": "On 11/4/19 all distributors with recalled product were immediately notified of the recall by phone. 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