Device Recall Axial Torque Limiting Driver

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of: CA, FL, IN, MA, MI, OH, PA, TN UT, VA and the country of UNITED KINGDOM
  • Description du dispositif
    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 click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bradshaw Medical Inc., 10325 58th Pl, Kenosha WI 53144-7872
  • Société-mère du fabricant (2017)
  • Source
    USFDA