{ "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": "131288", "product_res_number": "Z-0535-2015", "event_date_initiated": "2014-09-08", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2017-11-29", "res_event_number": "69471", "product_code": "DRC", "product_description": "A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.", "code_info": "1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410.   2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213.   3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312.   4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410.   5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410.   6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.", "firm_fei_number": "1421101", "recalling_firm": "Instrumed International, Inc.", "address_1": "626 Cooper Ct", "city": "Schaumburg", "state": "IL", "postal_code": "60173-4537", "additional_info_contact": "Ms. Jennifer S. Staunton\n847-908-6119", "reason_for_recall": "The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as \"Pre-Amendment\" devices.", "root_cause_description": "No Marketing Application", "action": "Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.", "product_quantity": "11 trocars", "distribution_pattern": "Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.", "openfda": { "k_number": [ "K132943", "K212625", "K974742", "K081986", "K854294", "K940036", "K241042", "K221707", "K974745", "K122832", "K072278", "K890209", "K924338", "K871377", "K011727", "K772369", "K895455", "K111644", "K172934", "K964302", "K951448", "K911462", "K172893", "K974743", "K840529", "K122587", "K854293", "K240246", "K061070", "K871378", "K022257", "K895454", "K914985", "K811964", "K853132", "K771261", "K936247", "K011373", "K172950", "K911483", "K781221", "K011349", "K965051", "K022117", "K900664", "K210328", "K893707", "K913267", "K130843", "K871382", "K170671" ], "registration_number": [ "2029015", "3013388519", "3005528784", "1058584", "2029275", "3012179728", "3003528228", "3001408183", "3009750712", "1627186", "3013986346", "3015976667", "3006950086", "3012454208", "1625425", "1319211", "3015972835", "2011171", "3010200163", "3012267976", "3023191945", "3011600579", "2518902", "3013400708", "1222313", "3008824097", "3030516433", "8039051", "2433012", "3004111573", "3011642792", "1048735", "3015309643", "1836564", "8010697", "9616088", "3006554912", "3027815", "1018470", "3010041511", "1724474", "3015398570", "1061927", "3009393076", "9680519", "3009605245", "3037050339", "3015490794", "1921846", "3030733800", "3005273623", "1000523114", "3005334138", "3045058049", "1423537", "3003877407", "3008452825", "1721504", "3015895045", "1721676", "2640138", "3010665433", "2182269", "3008770252", "2951215", "1061124", "1000112137", "3013557562", "3007361214", "3016950436", "1037885", "3030188041", "1820334", "3030447506", "3035708926", "3012452798", "3016994953", "3033589330", "3012536737", "9612030", "1417485", "1646747", "3015225571", "3003882387", "2022435", "1928237", "3008902714", "3010273872", "3030446844", "2030624", "1123137", "1216677", "3011137372", "2431166", "3016248634" ], "fei_number": [ "3002902735", "1000219637", "3005747797", "3013388519", "3005528784", "3001236905", "3012179728", "3003528228", "3001408183", "1000127185", "3009750712", "1627186", "3013986346", "3015976667", "3006950086", "3000206435", "1000221492", "3012454208", "1625425", "1319211", "3015972835", "2011171", "3010200163", "3012267976", "3023191945", "3011600579", "2523865", "3013400708", "2518902", "3008824097", "5638", "3030516433", "2433012", "1000306431", "3004111573", "3011642792", "1048735", "3015309643", "1000121050", "3006554912", "1018470", "3010041511", "3015398570", "3009393076", "3009605245", "3037050339", "3015490794", "1921846", "1000160458", "3030733800", "3005273623", "1000523114", "3003316544", "3005334138", "3045058049", "3003877407", "1721504", "3008452825", "3015895045", "1721676", "3010665433", "1000512168", "2182269", "3008770252", "3003370911", "1000112137", "3002806934", "3013557562", "3007361214", "3016950436", "1037885", "3030188041", "1820334", "3030447506", "3035708926", "3000203000", "3012452798", "3016994953", "3033589330", "3012536737", "1000160162", "1417485", "3015225571", "3003882387", "2022435", "3003094851", "1928237", "3008902714", "3010273872", "3030446844", "3004053982", "1000123180", "1216677", "3016248634", "3002631673" ], "device_name": "Trocar", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1390", "device_class": "2" } } ] }