{ "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": "123114", "product_res_number": "Z-0475-2014", "event_date_initiated": "2013-11-12", "event_date_posted": "2013-12-10", "recall_status": "Terminated", "event_date_terminated": "2014-10-15", "res_event_number": "66717", "product_code": "HSN", "k_numbers": [ "K120906" ], "product_description": "Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6\r\n\r\nTotal ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: \" Rheumatoid arthritis. \" Post-traumatic arthritis. \" Degenerative arthritis. This device is intended for cemented use only.", "code_info": "Part Number \tLot Number 00450001100\t62072174 00450001100\t62248802 00450001100\t62264833 00450001100\t62267033 00450001100\t62279041 00450001100\t62279043 00450001100\t62331803 00450001100\t62331808 00450001100\t62337755 00450001100\t62343558 00450001100\t62357496 00450001100\t62357497 00450001100\t62397412 00450001100\t62397413 00450001100\t62430803 00450001200\t11007903 00450001200\t11008443 00450001200\t62168362 00450001200\t62239775 00450001200\t62239789 00450001200\t62267626 00450001200\t62267627 00450001200\t62279044 00450001200\t62279050 00450001600\t62168363 00450001600\t62239794 00450001600\t62264836 00450001600\t62264837 00450001600\t62267631 00450001600\t62290823 00450001600\t62290824 00450001600\t62297847 00450001600\t62297848 00450001600\t62310752 00450001600\t62316170 00450001600\t62323809 00450001600\t62331810 00450001600\t62337757 00450001600\t62349862 00450001600\t62357499 00450001600\t62372416 00450001600\t62405309 00450001600\t62419534 00450001200\t62285546 00450001200\t62290833 00450001200\t62290835 00450001200\t62372414 00450001200\t62375863 00450001200\t62397414 00450001200\t62405304 00450001200\t62416035 00450001200\t62419530 00450001200\t62430804 00450001300\t62160227 00450001300\t62163379 00450001300\t62215393 00450001300\t62264834 00450001300\t62267628 00450001300\t62267629 00450001300\t62279045 00450001300\t62279051 00450001300\t62285548 00450001300\t62290836 00450001300\t62299551 00450001300\t62331811 00450001300\t62337756 00450001300\t62349856 00450001300\t62349857 00450001300\t62368383 00450001300\t62375865 00450001300\t62375868 00450001300\t62378060 00450001300\t62397415 00450001300\t62397416 00450001300\t62409032 00450001300\t62409033 00450001300\t62416036 00450001300\t62419532 00450001300\t62430805 00450001400\t11007904 00450001400\t11008529 00450001400\t62163382 00450001400\t62208153 00450001400\t62239776 00450001400\t62239786 00450001400\t62264835 00450001400\t62279052 00450001400\t62290829 00450001400\t62299552 00450001400\t62305739 00450001400\t62310750 00450001400\t62316168 00450001400\t62316169 00450001400\t62343549 00450001400\t62343550 00450001400\t62343551 00450001400\t62349858 00450001400\t62368384 00450001400\t62372415 00450001400\t62378062 00450001400\t62393803 00450001400\t62393804 00450001400\t62397417 00450001400\t62405306 00450001400\t62409034 00450001400\t62416038 00450001400\t62416039 00450001400\t62416040 00450001400\t62419533 00450001400\t62459855 00450001500\t62072172 00450001500\t62208154 00450001500\t62215392 00450001500\t62220672 00450001500\t62220674 00450001500\t62226570 00450001500\t62279046 00450001500\t62279053 00450001500\t62285550 00450001500\t62290842 00450001500\t62331809 00450001500\t62349859 00450001500\t62349861 00450001500\t62357498 00450001500\t62358906 00450001500\t62378063 00450001500\t62393805 00450001500\t62397418 00450001500\t62405308 00450001500\t62416042 00450001500\t62439673 00450001600\t11007906 Part Number \tLot Number 00830001100\t62264850 00830001100\t62316172 00830001100\t62323776 00830001100\t62337212 00830001100\t62357509 00830001200\t62204729 00830001200\t62215395 00830001200\t62316173 00830001200\t62323778 00830001200\t62331816 00830001200\t62343559 00830001300\t11008422 00830001300\t62204730 00830001300\t62220676 00830001300\t62267038 00830001300\t62267040 00830001300\t62323781 00830001300\t62331817 00830001300\t62337216 00830001300\t62349869 00830001300\t62409040 00830001400\t62208150 00830001400\t62264851 00830001400\t62310756 00830001400\t62316177 00830001400\t62323783 00830001400\t62343560 00830001400\t62343561 00830001400\t62368388 00830001500\t62204731 00830001500\t62215396 00830001500\t62305743 00830001500\t62323784 00830001500\t62343563 00830001500\t62357510 00830001500\t62428994 00830001600\t62264852 00830001600\t62299553 00830001600\t62316174 00830001600\t62323786 00830001600\t62337210 00830001600\t62343565 00830001600\t62357511", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer, Inc.", "address_1": "345 E Main St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2746", "additional_info_contact": "800-613-6131", "reason_for_recall": "As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media", "root_cause_description": "Manufacturing material removal", "action": "Zimmer sent an URGENT MEDICAL DEVICE RECALL notification letter dated November 12, 2013 to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to locate and remove the affected product from their inventory and notify their Zimmer representataive. The Zimmer representative will remove the recalled product from their facility. For patients that previously had the affected product implanted, consignees were instructed to continue their operative follow up routine. Consignees with questions were instructed to call 1-877-946-2761.\r\nFor questions regarding this recall call 800-613-6131.", "product_quantity": "269 units (US) 110 units (outside US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.", "openfda": { "k_number": [ "K172633", "K182878", "K240475", "K223227", "K141740", "K231699", "K201507", "K170968", "K770420", "K153008", "K761021", "K180730", "K202019", "K100886", "K192994", "K061749", "K020541", "K761020", "K211883", "K803167", "K171067", "K240259", "K103374", "K193067", "K123954", "K191393", "K120906", "K131283", "K183343", "K191380", "K210390", "K240591", "K252454", "K110360", "K230717", "K122395", "K152217", "K051023", "K090076", "K222835", "K253159", "K230313", "K142117", "K171004", "K230462", "K232595", "K250641", "K060544", "K241999", "K800530", "K250037", "K770421", "K140749", "K192778", "K242868", "K053569", "K241482", "K181557", "K920802", "K151459", "K133585", "K162795", "K130533", "K153452", "K202815", "K123059", "K232002", "K202373" ], "registration_number": [ "1020279", "3020703621", "2134285", "3010123256", "3011189525", "1531174", "1822565", "3006272282", "1423662", "3014833750", "3005144609", "3015526568", "3009971621", "2027062", "3010375065", "3010178296", "2133928", "3007922509", "1825034", "3009882462", "1835572", "1835251", "3012234585", "1043534", "1225838", "3009923578", "3009888740", "3007648354", "3009826895", "3008421730", "1720929", "3020745236", "3010470577", "1043653", "1051526", "3027071765", "3006217744", "3010667733", "1649518", "3008868758", "3006791286", "1424434", "1220477", "2090040", "1018470", "1450662", "3011277306", "3004513872", "3009887475", "3010009693", "3006128100", "3009973336", "1038671", "3011015572", "1526534", "1226544", "3013014058", "1221934", "3023852420", "1834331", "1057425", "1721676", "1424263", "3005596372", "3007353762", "3033509898", "1818910", "2249615", "3008650117", "3010057495", "3012275107", "1000200989", "1221053", "3008658204", "3010039400", "3004153896", "3004635447", "2246552", "3007740680", "3014680149", "3036756245", "1834179", "3016084569", "3003477135", "3010141347", "1724955", "2183744", "3025603301", "3010047402", "3010462278", "3010162973", "2528981" ], "fei_number": [ "1020279", "3003128516", "3020703621", "3010123256", "3011189525", "3000717902", "3001452082", "1000221916", "3006272282", "3014833750", "3005144609", "3015526568", "3009971621", "2027062", "3002795782", "3010375065", "3007922509", "1825034", "3009882462", "3012234585", "1043534", "1000306340", "3001644153", "3000205591", "3002807041", "3009923578", "3009888740", "3001236277", "3007648354", "3009826895", "3008421730", "1720929", "3020745236", "3003110073", "3010470577", "1000220733", "1043653", "1051526", "3027071765", "3006217744", "3010667733", "3008868758", "3006791286", "1220477", "1018470", "1450662", "3011277306", "3004513872", "3009887475", "3001049282", "3010009693", "3006128100", "3003142829", "3009973336", "1038671", "3011015572", "1000160371", "1526534", "3002993297", "3013014058", "1221934", "3023852420", "3002287318", "1721676", "3000215273", "3005596372", "3007353762", "3033509898", "1818910", "3008650117", "3010057495", "3012275107", "1000200989", "1221053", "3008658204", "3010039400", "3004153896", "3004635447", "2246552", "3007740680", "3014680149", "3036756245", "3016084569", "3003477135", "3010141347", "3003015552", "2183744", "3025603301", "3010047402", "3010462278", "2528981", "3002615969" ], "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3110", "device_class": "2" } } ] }