{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176824", "product_res_number": "Z-0306-2020", "event_date_initiated": "2019-10-10", "event_date_created": "2019-11-07", "recall_status": "Terminated", "event_date_terminated": "2020-05-19", "res_event_number": "83962", "product_code": "HSN", "k_numbers": [ "K120906" ], "product_description": "TM Ankle and Ankle Talus L/R, Item Nos. 00450001100\n00450001200\n00450001300\n00450001400\n00450001500\n00450001600\n00450002100\n00450002200\n00450002300\n00450002400\n00450002500\n00450002600", "code_info": "All product manufactured prior to January 2014.", "firm_fei_number": "1000220733", "recalling_firm": "Zimmer Biomet, Inc.", "address_1": "1800 W Center St", "city": "Warsaw", "state": "IN", "postal_code": "46580-2304", "additional_info_contact": "Zimmer Biomet Customer Service\n574-371-3071", "reason_for_recall": "Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).", "root_cause_description": "Packaging change control", "action": "The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags.\n\nCustomers were asked to take the following actions:\n\n1. Review this notification and ensure that pertinent personnel are aware of the contents.\n2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time.\n3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected.\n4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components.\n5. Complete the Certificate of Acknowledgement and return to the firm.\n6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation.\n\nIf you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.", "product_quantity": "5,459,583 total devices", "distribution_pattern": "Distributed nationwide.", "openfda": { "k_number": [ "K110360", "K192994", "K240591", "K191380", "K142117", "K252454", "K202815", "K241482", "K202373", "K210390", "K240259", "K061749", "K122395", "K770421", "K770420", "K240475", "K230462", "K920802", "K191393", "K192778", "K201507", "K152217", "K803167", "K171067", "K230313", "K232002", "K181557", "K053569", "K120906", "K180730", "K222835", "K800530", "K130533", "K230717", "K231699", "K202019", "K051023", "K140749", "K090076", "K761020", "K182878", "K123059", "K162795", "K123954", "K020541", "K761021", "K250641", "K151459", "K242868", "K133585", "K141740", "K211883", "K193067", "K170968", "K223227", "K172633", "K232595", "K183343", "K060544", "K103374", "K131283", "K100886", "K171004", "K153008", "K241999", "K153452", "K253159", "K250037" ], "registration_number": [ "1724955", "1038671", "3027071765", "3014833750", "1220477", "3010141347", "1051526", "1649518", "3014680149", "3013014058", "1450662", "3005144609", "3007922509", "1531174", "2528981", "3008658204", "1225838", "3020745236", "1834179", "3009887475", "2027062", "3033509898", "1720929", "3008421730", "1226544", "1835251", "3006217744", "3023852420", "1721676", "1221934", "3020703621", "3009923578", "1834331", "3004635447", "1423662", "3015526568", "3010375065", "3016084569", "3010009693", "3010047402", "1043653", "1221053", "1057425", "3012234585", "3005596372", "3008868758", "3009973336", "3012275107", "3004153896", "1526534", "3010057495", "2133928", "3004513872", "3011015572", "1822565", "2183744", "2246552", "2090040", "1018470", "3011277306", "3010039400", "1825034", "1424263", "3006791286", "3010667733", "3008650117", "3010470577", "3009882462", "1835572", "2134285", "1020279", "3007740680", "3010123256", "2249615", "3010162973", "3010178296", "3007353762", "3009826895", "3003477135", "3009971621", "3009888740", "3006272282", "3025603301", "3011189525", "3036756245", "3007648354", "1000200989", "1043534", "1424434", "3010462278", "1818910", "3006128100" ], "fei_number": [ "3027071765", "1038671", "3001236277", "3014833750", "1220477", "3003015552", "3010141347", "1051526", "3014680149", "3013014058", "1450662", "1000220733", "3005144609", "3007922509", "3001644153", "2528981", "3008658204", "3020745236", "3002615969", "3009887475", "2027062", "3033509898", "1720929", "3008421730", "3006217744", "3002993297", "3023852420", "1721676", "1221934", "3020703621", "3009923578", "3004635447", "3001452082", "3015526568", "3010375065", "3016084569", "3010009693", "3010047402", "3000215273", "1043653", "1000221916", "3002795782", "1221053", "3012234585", "3005596372", "3001049282", "3008868758", "3009973336", "3012275107", "3004153896", "1526534", "3010057495", "1000306340", "3000205591", "3004513872", "3003128516", "3011015572", "2183744", "2246552", "3002287318", "1018470", "3011277306", "3010039400", "1825034", "3006791286", "3010667733", "3008650117", "3010470577", "3009882462", "1000160371", "1020279", "3007740680", "3010123256", "3007353762", "3009826895", "3003477135", "3009971621", "3002807041", "3009888740", "3006272282", "3025603301", "3011189525", "3036756245", "3007648354", "1000200989", "3000717902", "1043534", "3010462278", "1818910", "3003142829", "3006128100", "3003110073" ], "device_name": "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3110", "device_class": "2" } } ] }