Reported May 18, 2016 · Terminated
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a…
Bradshaw Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bradshaw Medical Inc. · 10325 58th Pl · Kenosha, WI · 53144-7872
Is this the product you have?
- Axial Torque Limiting
- Driver (1st generation) Product UsageThe 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
- Lot codes and dates
- 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 -030THRU 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
6200-1109513884200930054351422720093006435142282009300743514229200930084351423020093009935168282009411377518909201008225751994220101525715227012010373025-201037317414-525035-00538133538133001-030538134538134001-015548080548080001-015550475550475001-015552169552169001-020553131553131001-015553710553710001-015558873558873001-010567568567568001-010569141569141001-015PARD01085530249351400001-002L070-00455706591525-10-1
AND050534799BRM259FA535830BRM292GA537840BRM362AA539698BRN046AA540726BRN073AA543837BRN171BA544323BRN194AA003544323-1BRN194AA001-002
TO 010 CHANGED TO BRP214AA AFTER REWORK004-014547606BRN285EA548612BRN317DA549604BRN348VA554050BRP102AA555027BRP107CA-001
-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 to556873BRP192VA558042BRP225AA560135BRP283AA561731BRP324AA562453BRP345AA563429BRR010FA565115BRR048AA571756BRR255BA
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 TO005652-1-1030050092346420510872510872512031512031515511515511525260525260563264563264-01
025908.133-15358861011-65594880913-65688160214-65705661014-6X060-032352267252267252594152594153524453524453524553524553581753581752594252594253177653177
- 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
- Amount recalled
- 3,760 units
Where it was sold
Why it was recalled
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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