{ "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": "89981", "product_res_number": "Z-0493-2011", "event_date_initiated": "2010-02-16", "event_date_posted": "2010-12-01", "recall_status": "Terminated", "event_date_terminated": "2011-10-05", "res_event_number": "55119", "product_code": "HWN", "product_description": "Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN.\nIntended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.", "code_info": "lot # 60869302 and lot # 60963801", "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": "574-267-6131", "reason_for_recall": "The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.", "root_cause_description": "Nonconforming Material/Component", "action": "Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall.\nLocate all instruments and quarantine them immediately.\nCount all affected product in their territory and record the data on the\nInventory Return Certification Form included with the letter.\nFax a copy of the completed Inventory Return Form to:\nZimmer, Inc. at (574) 372-4265.\nReturn the recalled product along with the original completed Inventory Return Certification Form to:\nZimmer Distribution Center\nAttn: Product Service\n1777 West Center Street\nWarsaw, IN 46580\n\nFor questions customers were instructed to contact their Zimmer Sales Representative.\nFor questions regarding this recall call 1 - (800) 613-6131.", "product_quantity": "217 all products", "distribution_pattern": "Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,", "openfda": { "k_number": [ "K792253", "K760970", "K770349", "K854241" ], "device_name": "Instrument, Compression", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1", "registration_number": [ "", "3008583793", "3005739886", "3004176895", "3017565094", "8010379", "9611281", "1530390", "3042248499", "1828288", "1935627", "3004464325", "3006783837", "3004049923", "3010509633", "1835572", "3007125392", "3010097171", "1833986", "3014938863", "9611827", "8010935", "1825034", "1219518", "3009971621", "2027754", "3042953190", "3009051471", "3014257776", "3009790163", "3006846753", "8043862", "3009380063", "1835998", "3010235355", "3003407244", "3005061536", "3004774118", "1421101", "8040278", "1722824", "3009882675", "3015516266", "3009509485", "3006943846", "9610612", "3022159082", "3006128100", "3009106092", "3010303097", "8010405", "9614093", "3037407500", 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