{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Kenosha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "73873", "recalling_firm": "Bradshaw Medical Inc.", "address_1": "10325 58th Pl", "address_2": "N/A", "postal_code": "53144-7872", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "N/A", "distribution_pattern": "US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM", "recall_number": "Z-1637-2016", "product_description": "Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical \u0018click\u0019 style hand torque tool which presents an audible and tactile \u0018click\u0019 when the maximum desired torque is reached.", "product_quantity": "3,760 units", "reason_for_recall": "A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.", "recall_initiation_date": "20150202", "center_classification_date": "20160510", "termination_date": "20200110", "report_date": "20160518", "code_info": "Part Number BMI # Customer Lot Code 11-5000-018 512833 102551 512835 102848 527192 OP-CS-I-0026 TO 0046 550398 OP-CS-I-0223 TO 0232 561041 561041-001 TO -030 6200-1109 513884 2009300543 514227 2009300643 514228 2009300743 514229 2009300843 514230 2009300993 516828 2009411377 518909 2010082257 519942 2010152571 522701 2010373025-2010373174 14-525035-00 538133 538133 001-030 538134 538134 001-015 548080 548080 001-015 550475 550475 001-015 552169 552169 001-020 553131 553131 001-015 553710 553710 001-015 558873 558873 001-010 567568 567568 001-010 569141 569141 001-015 PARD01085 530249 351400 001-002 L070-0045 570659 1525-10-1 THRU 1525-10-2 694.002 523947 BRL237AA001 523948 BRL237AA 002 TO 092 527249 BRM032AA-001 TO 015 529395 BRM061AA 001 TO 030 528469 BRM061AA 001 TO 050 534799 BRM259FA 535830 BRM292GA 537840 BRM362AA 539698 BRN046AA 540726 BRN073AA 543837 BRN171BA 544323 BRN194AA003 544323-1 BRN194AA 001-002 AND 004-014 547606 BRN285EA 548612 BRN317DA 549604 BRN348VA 554050 BRP102AA 555027 BRP107CA-001 TO 010 CHANGED TO BRP214AA AFTER REWORK 556873 BRP192VA 558042 BRP225AA 560135 BRP283AA 561731 BRP324AA 562453 BRP345AA 563429 BRR010FA 565115 BRR048AA 571756 BRR255BA -001 TO 010 572999 BRR293FA ALSO 572999-001 TO 025 K2-01-2473-01 503404 LDS-001d to -015 509497 AAHG-001 TO -030 509498 AAHV-001 TO -025 514731 ACAV-001 TO -030 518702 AEXJ-001 TO -035 520216 AFXM-001 TO -010 522688 AGRK-001 TO -085 524265 AJNC-001 TO -015 526562 AKLA-001 TO -050 532140 ATDE-001 TO -015 533737 AUAF-001 TO -020 537141 AYGY-001 TO -015 541350 BDRY-001 TO -025 549451 BMCU-001 TO -019 550756 BMCU-020 TO -070 552289 BRRL-001 TO -030 556336 BWEE-001 TO -015 563714 CHCU-001 TO -015 565297 CLWD-001 TO -045 K2-08-2294-01 516879 ADRF-001 TO -010 521965 AGKL-001 TO -025 521966 AGKL-026 TO -040 525435 AJYW-001 TO -010 525855 AJYW-001 TO -040 527600 AKYY-010 TO -030 532139 ATCU-001 TO -035 541358 BDVV-001 TO -015 552078 BRKB-001 TO -060 552286 BRRR-001 TO -060 575988 DHDB-001 to -020 K2-12-2044-01 509002 AAEM-001 TO -006 518290 AEEJ-010 TO -020 523307 AJAK-001 TO -015 529220 AMEM-001 TO -010 554653 BVLJ-001 TO -010 557778 BYCR-001 TO -015 565304 CLYJ-001 TO -005 570207 DBDH-001 TO -010 11-K03-5001 566401 B411 TO B420 281-1-10220 535841 535841-001 to 005 535842 535842-001 to 031 541403 541403 005, 006, 030 541403-1 541403-1 001-064 543008 543008-001 to 030 544168 544168-001 to 010 544169 544169-001 to 015 545627 545627-001 to 005 546471 546471-001 to -010 550013 550013-001 to 020 550831 550831-001 to 010 552163 552163-001 to 005 554468 554468-001 to 010 558407 558407-001 to 010 560471 560471-001 to 015 563037 563037-001 to 025 571303 571303-001 to 005 652-1-10300 500923 46420 510872 510872 512031 512031 515511 515511 525260 525260 563264 563264-01 to 05 723-454 566247 566247-001 to 003 91-1112 512367 AL512367B 001 TO 008 520386 AL520386B 001 TO 012 521170 AL521170B 001 TO 003 533351 AL533351B 001-015 545459 AL545459B-001 TO 015 558280 AL558280B 001 TO 010 560756 AL560756B 001 TO 010 567356 AL567356B-001 TO 010 95-0127 500382 AL500382A 504238 AL504238A 001 TO 045 507588 AL507588A 001 TO 015 507589 AL507589A 001 TO 010 515870 AL515870A 001 TO 008 520385 AL520385A 001 TO 020 560882 AL560882A-001 TO 010 563933 AL563933A-001 TO 010 572915 AL572915A-001 TO 015 03.811.109 544776 113056-01 562281 7532121-01 TO 25 15-614-000-XBOLT 557962 557962-001 TO 010 565491 565491-001 TO 025 908.133-1 535886 1011-6 559488 0913-6 568816 0214-6 570566 1014-6 X060-0323 522672 522672 525941 525941 535244 535244 535245 535245 535817 535817 525942 525942 531776 53177" } ] }