{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161456", "product_res_number": "Z-0904-2018", "event_date_initiated": "2017-07-26", "event_date_created": "2018-03-05", "recall_status": "Terminated", "event_date_terminated": "2018-09-10", "res_event_number": "79157", "product_code": "HTO", "product_description": "3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S\n\nReaming Rods are intended for guiding of reamers during orthopedic surgery.", "code_info": "Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632\t4/3/2017\t2026-02-28 H311229\t4/16/2017\t2026-03-31 H311228\t4/28/2017\t2026-03-31 H311231\t4/28/2017\t2026-03-31 H319172\t4/28/2017\t2026-03-31 H319175\t4/28/2017\t2026-03-31 H318789\t5/4/2017\t2026-03-31 H319171\t5/4/2017\t2026-03-31 H327068\t5/4/2017\t2026-03-31 H311226\t5/6/2017\t2026-03-31 H311225\t5/11/2017\t2026-04-30 H311224\t5/12/2017\t2026-04-30 H327067\t5/12/2017\t2026-04-30 H327066\t5/18/2017\t2026-04-30", "firm_fei_number": "3008812560", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "city": "West Chester", "state": "PA", "postal_code": "19380-5986", "additional_info_contact": "Anne Brisson\n610-719-5443", "reason_for_recall": "Possible lack of product sterility due to potential gaps/channeling in the seal of the package.", "root_cause_description": "Process control", "action": "The firm, DePuy Synthes, sent an \"URGENT NOTICE: MEDICAL DEVICE RECALL\" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: \nIf you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps:\n Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided.\n Send a copy of the completed Verification Section to Synthes by:\no Fax: 844-721-3045 or\no Scan/email: Synthes5735@stericycle.com\nNote: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification.\n\nIf you DO have any of the identified devices, and are returning the product for replacement, please take the following steps:\n Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number.\n Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return\n Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided.\n Return the Verification Section (page 4 of this letter) with the product to:\no Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.\n Send a copy of the completed Verification Section to Synthes by:\no Fax: 844-721-3045 or\no Scan/email: Synthes5735@stericycle.com\n\nNote: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea", "product_quantity": "960", "distribution_pattern": "Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.", "openfda": { "k_number": [ "K903248", "K954915", "K111437", "K885100", "K870845", "K790996", "K811081", "K042899", 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