{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "182219", "product_res_number": "Z-0479-2021", "event_date_initiated": "2020-06-19", "event_date_created": "2020-11-20", "recall_status": "Open, Classified", "res_event_number": "85943", "product_code": "HSX", "k_numbers": [ "K191325" ], "product_description": "EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.", "code_info": "all lot numbers", "firm_fei_number": "1000116912", "recalling_firm": "Encore Medical, LP", "address_1": "9800 Metric Blvd", "city": "Austin", "state": "TX", "postal_code": "78758-5445", "additional_info_contact": "Teffany Hutto\n512-834-6200", "reason_for_recall": "There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.", "root_cause_description": "Other", "action": "The method of notification was via e-mail to surgical sales agents, and the notices were issued on 06/18/2020. Additionally, a notification to return the affected drills for replacement were sent via e-mail to affected surgical agents on 07/20/20.\n\nThe following recommendations should be communicated to the implanting surgeons:\n Sales Agents Action:\nTo avoid the potential binding, the following is recommended:\n\" Use a plunge mill approach, i.e. plunge the drill in and out of the drill guide bushing a few times slowly until the hole is fully prepared.\n\" Use of saline or fat to keep the drill lubricated during use.\n\" Inspect all instrumentation prior to use to identify any wear, breakage or damage.\nAlong with the notification, the communication includes an acknowledgment form that should be completed and returned to confirm that the instructions provided have been read and understood. THE ACKNOWLEDGEMENT SHOULD BE REVIEWED AND COMPLETED BY JULY 6, 2020.For questions, contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.", "product_quantity": "28 units", "distribution_pattern": "US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA..\nNo OUS Consignees.", "openfda": { "k_number": [ "K771511", "K941606", "K073175", "K792240", "K894068", "K242711", "K100197", "K212307", "K172650", "K061011", "K910807", "K061779", "K800640", "K161741", "K211895", "K844706", "K862136", "K121974", "K221292", "K261609", "K191996", "K203697", "K251771", "K211471", "K202207", "K191325", "K101206", "K160738", "K873970", "K931214", "K251453", "K173970", "K945613", "K191211", "K081351", "K161060", "K854325", "K915240", "K872735", "K910083", "K112301", "K190085", "K912735", "K241260", "K010685", "K862837", "K170344", "K113038", "K073248", "K900619", "K200151", "K032824", "K251618", "K861715", "K880155", "K260796", "K120262", "K033363", "K926231", 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"1818910", "3012523063", "3005144609", "3002854251", "3020155054", "1000136269", "3002924544", "3001548076", "1421101", "3001236549", "3017597868", "3003128516", "3004153240", "3010220595", "3013055499", "3010163695", "3014763043", "3012755988", "1000120613", "3008868758", "3015806723", "3004154314", "3000717902", "3022142628", "1043653", "3002807893", "3005985723", "1000143502", "3010375065", "3010097171", "3003639920", "3010331645", "2246552", "3003070421", "1048735", "3003292403", "3021008900", "3007282753", "3000215273", "3009973505", "3011295718", "3000264985", "3007932279", "3007993775", "3016851379", "3020703621", "1219602", "3002808269", "1000137563", "1721676", "1828464", "1825034", "3010287685", "3030412764", "3002287318", "1828288", "3011187779", "3003110073", "3010009693", "3002807295", "3005180920", "3003998208", "3010049501", "3016438694" ], "device_name": "Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3520", "device_class": "2" } } ] }