Events

Recall of Device Recall Axial Torque Limiting Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bradshaw Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73873
  • Event Risk Class
    Class 2
  • Event Number
    Z-1637-2016
  • Event Initiated Date
    2015-02-02
  • Event Date Posted
    2016-05-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145265
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wrench - Product Code HXC
  • Reason
    A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
  • Action
    Consignees were sent a Bradshaw Medical "Product Withdrawal Notice" letter, date marked starting February 2, 2015. The letter specified the Part Number, Lot Number (s) and Shipped date for each consignee. The letter described the product and advised consignees to discontinue use of the product. Requested consignees to complete and return the Customer /Distribution verification Form to BMI Regulatory Affairs FAX (262) 925-1380 and to further send the "Withdrawal Notice and Customer Verification Form" to all customers to whom they have distributed the product.

Device

Device Recall Axial Torque Limiting Driver
  • Model / Serial
    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
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    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
  • 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 click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
  • Manufacturer
    Bradshaw Medical Inc.

Manufacturer

Bradshaw Medical Inc.
  • Manufacturer Address
    Bradshaw Medical Inc., 10325 58th Pl, Kenosha WI 53144-7872
  • Manufacturer Parent Company (2017)
    Bradshaw Medical Inc.
  • Source
    USFDA