{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "123120", "product_res_number": "Z-0476-2014", "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 Right Sizes 1-6\n\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 00450002100\t62163375 00450002100\t62248804 00450002100\t62248805 00450002100\t62267632 00450002100\t62279047 00450002500\t62220671 00450002500\t62220675 00450002500\t62226571 00450002500\t62279042 00450002500\t62279049 00450002500\t62285553 00450002500\t62290846 00450002500\t62290857 00450002500\t62343556 00450002500\t62357507 00450002500\t62368386 00450002500\t62375875 00450002500\t62405317 00450002500\t62409039 00450002500\t62419539 00450002500\t62428993 00450002500\t62439679 00450002500\t62442236 00450002600\t11007905 00450002600\t62163386 00450002600\t62262903 00450002600\t62264848 00450002600\t62290827 00450002600\t62297849 00450002100\t62287975 00450002100\t62331805 00450002100\t62337206 00450002100\t62337758 00450002100\t62349863 00450002100\t62357502 00450002100\t62358897 00450002100\t62397419 00450002100\t62397420 00450002200\t62163377 00450002200\t62239777 00450002200\t62239790 00450002200\t62267633 00450002200\t62267635 00450002200\t62279048 00450002200\t62279054 00450002200\t62290840 00450002200\t62290843 00450002200\t62337207 00450002200\t62343552 00450002200\t62357504 00450002200\t62375870 00450002200\t62405311 00450002200\t62416043 00450002200\t62419536 00450002200\t62453776 00450002200\t62453777 00450002200\t62459876 00450002300\t11009092 00450002300\t62163380 00450002300\t62215391 00450002300\t62215394 00450002300\t62220673 00450002300\t62267034 00450002300\t62267636 00450002300\t62279055 00450002300\t62285552 00450002300\t62305740 00450002300\t62310753 00450002300\t62323811 00450002300\t62337208 00450002300\t62337759 00450002300\t62349864 00450002300\t62357505 00450002300\t62357506 00450002300\t62372417 00450002300\t62375873 00450002300\t62378065 00450002300\t62409035 00450002300\t62409036 00450002300\t62416044 00450002300\t62419537 00450002300\t62453778 00450002400\t62163383 00450002400\t62208155 00450002400\t62239778 00450002400\t62267035 00450002400\t62267036 00450002400\t62267637 00450002400\t62267638 00450002400\t62297851 00450002400\t62305741 00450002400\t62305742 00450002400\t62310754 00450002400\t62316171 00450002400\t62343554 00450002400\t62343555 00450002400\t62349866 00450002400\t62368385 00450002400\t62372419 00450002400\t62375874 00450002400\t62378066 00450002400\t62393806 00450002400\t62397421 00450002400\t62405314 00450002400\t62405315 00450002400\t62409037 00450002400\t62409038 00450002400\t62416045 00450002400\t62416047 00450002400\t62419538 00450002400\t62453782 00450002400\t62459863 00450002400\t62459864 00450002400\t62459866 00450002500\t11008421 00450002500\t11008423 00450002500\t62163384 00450002500\t62208156 00450002600\t62297850 00450002600\t62310755 00450002600\t62331806 00450002600\t62331812 00450002600\t62337209 00450002600\t62349867 00450002600\t62357508 00450002600\t62358902 00450002600\t62368387 00450002600\t62405319 00450002600\t62419540 00830002100\t62264853 00830002100\t62316175 00830002100\t62323787 00830002100\t62337211 00830002100\t62349871 00830002100\t62459838 00830002200\t11009324 00830002200\t62204732 00830002200\t62215397 00830002200\t62323788 00830002200\t62331820 00830002200\t62343566 00830002200\t62430807 00830002300\t62204765 00830002300\t62220678 00830002300\t62297852 00830002300\t62323789 00830002300\t62323794 00830002300\t62331822 00830002300\t62349872 00830002300\t62357512 00830002300\t62419528 00830002400\t62208151 00830002400\t62264855 00830002400\t62316178 00830002400\t62323790 00830002400\t62343567 00830002400\t62349873 00830002400\t62405298 00830002500\t62204734 00830002500\t62215398 00830002500\t62316176 00830002500\t62323792 00830002500\t62331823 00830002500\t62337217 00830002500\t62357513 00830002600\t62239781 00830002600\t62305744 00830002600\t62316179 00830002600\t62323796 00830002600\t62337220 00830002600\t62349874 00830002600\t62393802 00830002600\t62428995", "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.\nFor questions regarding this recall call 800-613-6131.", "product_quantity": "265 units (US) 114 units (outside US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.", "openfda": { "k_number": [ "K170968", "K920802", "K193067", "K053569", "K020541", "K770420", "K761021", "K223227", "K211883", "K140749", "K131283", "K181557", "K123059", "K210390", "K090076", "K152217", "K183343", "K231699", "K060544", "K100886", "K230313", "K162795", "K153008", "K232595", "K240475", "K250641", "K122395", "K202815", "K141740", "K761020", "K202019", "K192994", "K230717", "K133585", "K201507", "K253159", "K202373", "K110360", "K130533", "K191380", "K230462", "K222835", "K252454", "K800530", "K151459", "K192778", "K232002", "K153452", "K061749", "K171004", "K803167", "K142117", "K051023", "K103374", "K172633", "K241999", "K250037", "K242868", "K240591", "K123954", "K191393", "K120906", "K241482", "K240259", "K180730", "K182878", "K171067", "K770421" ], "registration_number": [ "3020703621", "1000200989", "3006791286", "1221053", "1220477", "1724955", "1835572", "1018470", "3010162973", "1825034", "3004513872", "1834179", "3009971621", "3011015572", "3009923578", "1221934", "3009887475", "1225838", "1051526", "1423662", "2133928", "3009826895", "1043534", "1720929", "3010141347", "3006128100", "1043653", "3014833750", "3008658204", "1424263", "1450662", "3008650117", "3009888740", "3036756245", "1531174", "2528981", "3007922509", "3009973336", "3010667733", "3010057495", "3014680149", "3007648354", "3010462278", "2246552", "3025603301", "3013014058", "2249615", "3033509898", "3010039400", "1526534", "3010123256", "1424434", "2027062", "1057425", "2134285", "3010178296", "1835251", "3020745236", "3009882462", "3023852420", "1834331", "1822565", "3004635447", "1020279", "3003477135", "1649518", "1038671", "3012234585", "2090040", "3006272282", "3011277306", "3008868758", "3010470577", "3010375065", "3016084569", "3005596372", "3015526568", "3008421730", "3027071765", "1721676", "2183744", "3011189525", "1226544", "3006217744", "3010009693", "3012275107", "3004153896", "3007353762", "1818910", "3010047402", "3005144609", "3007740680" ], "fei_number": [ "3020703621", "1000200989", "3006791286", "3002615969", "1221053", "3001452082", "1220477", "1018470", "3004513872", "1825034", "3009971621", "3011015572", "3002807041", "3009923578", "1221934", "3009887475", "1051526", "3002993297", "3003110073", "3009826895", "1043534", "1720929", "3010141347", "3006128100", "3002287318", "1043653", "3014833750", "3008658204", "1450662", "3008650117", "3009888740", "3036756245", "3000215273", "3003128516", "2528981", "3007922509", "3009973336", "3010667733", "3010057495", "3014680149", "3007648354", "3010462278", "2246552", "3025603301", "3003142829", "3013014058", "3033509898", "3010039400", "1526534", "3010123256", "1000306340", "3002795782", "2027062", "3001644153", "3020745236", "3009882462", "3023852420", "3004635447", "1020279", "3003477135", "1038671", "3012234585", "3006272282", "3011277306", "3008868758", "3010470577", "3001236277", "3010375065", "3016084569", "3005596372", "3000205591", "3003015552", "1000221916", "3015526568", "3001049282", "3008421730", "3027071765", "1721676", "2183744", "3000717902", "3011189525", "1000220733", "3006217744", "3010009693", "1000160371", "3012275107", "3004153896", "3007353762", "1818910", "3010047402", "3005144609", "3007740680" ], "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3110", "device_class": "2" } } ] }