{ "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": "184449", "product_res_number": "Z-0520-2021", "event_date_initiated": "2020-11-03", "event_date_created": "2020-12-02", "recall_status": "Terminated", "event_date_terminated": "2021-01-12", "res_event_number": "86748", "product_code": "NKG", "k_numbers": [ "K193129" ], "product_description": "Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.", "code_info": "Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948", "firm_fei_number": "3008599177", "recalling_firm": "K2M, Inc", "address_1": "600 Hope Pkwy SE", "city": "Leesburg", "state": "VA", "postal_code": "20175-4428", "additional_info_contact": "Maragrita Karan\n201-749-8389", "reason_for_recall": "Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.", "root_cause_description": "Nonconforming Material/Component", "action": "Our records indicate Stryker previously distributed catalog no. 7601-9001, Lot KTGG to your location in a Stryker Loaner Set. The nonconforming instrument was subsequently identified and quarantined during routine processing of loaner sets by Stryker at its Leesburg facility.\n\nThis communication is being made for notification purposes only. The only action requested of you is to complete the Business Reply form found on the following page and return it to the email addresses referenced in the form. \n\nIf you have any questions or concerns, please contact Stryker Regulatory Compliance at 201-749-8090. On behalf of Stryker we thank you sincerely for your help and support in completing the Business Reply Form and returning it to Stryker by November 6th, 2020.", "product_quantity": "4 devices", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K252327", "K211710", "K233366", "K171834", "K173047", "K183383", "K152211", "K181603", "K203319", "K192014", "K150570", "K232167", "K153370", "K153336", "K231840", "K170804", "K213871", "K172495", "K171444", "K142838", "K160428", "K161478", "K172194", "K143471", "K151031", "K182837", "K200571", "K250866", "K230614", "K254045", "K213654", "K153169", "K172594", "K211993", "K190631", "K152338", "K180025", "K150539", "K221307", "K151705", "K162300", "K200896", "K250332", "K253129", "K171250", "K162266", "K162575", "K201481", "K203125", "K151224", "K170647", "K161591", "K150474", "K192013", "K254165", "K150650", "K153386", "K162639", "K181949", "K191553", "K162136", "K193129", "K220810", "K190071", "K181350", 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