| Class 2 Device Recall Stryker Osteosynthesis | |
Date Initiated by Firm | January 26, 2012 |
Date Posted | July 16, 2012 |
Recall Status1 |
Terminated 3 on July 17, 2013 |
Recall Number | Z-2016-2012 |
Recall Event ID |
62051 |
510(K)Number | K020384 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
Product | Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430.
The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures. |
Code Information |
Code information is listed as Catalogue Number, Description and Lot Number (K Number) and is as follows: Catalog No. Description Lot No. 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K948548 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K102535 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K141824 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K155506 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K114992 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K395488 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K105496 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K923725 18291104S Arthrodesis Nail, LEFT ¿11.5 x 540mm K252636 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K137348 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K965902 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K695563 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K857453 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K862864 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K739588 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K245215 18291108S Arthrodesis Nail, LEFT ¿11.5 x 580mm K228300 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K219678 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K237017 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K133228 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K128489 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K960393 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K178967 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K923723 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K243246 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K252638 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K224305 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K172103 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K117496 18291112S Arthrodesis Nail, LEFT ¿11.5 x 620mm K261302 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K210496 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K189318 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K161024 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K255675 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K249773 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K206467 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K163054 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K153010 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K133229 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K129741 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K551191 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K579446 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K718554 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K395487 18291116S Arthrodesis Nail, LEFT ¿11.5 x 660mm K241618 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K221660 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K206470 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K133230 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K547010 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K477263 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K971898 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K862865 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K283864 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K395485 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K605002 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K207158 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K149929 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K114002 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K233828 18291120S Arthrodesis Nail, LEFT ¿11.5 x 700mm K869700 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K130896 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K784981 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K551192 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K579447 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K289448 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K177753 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K293136 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K250375 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K182394 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K269022 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K210938 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K166292 18291124S Arthrodesis Nail, LEFT ¿11.5 x 740mm K137364 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K579449 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K397977 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K890907 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K172104 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K130675 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K298308 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K186902 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K153008 18291128S Arthrodesis Nail, LEFT ¿11.5 x 780mm K130897 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K264288 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K113029 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K286419 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K250373 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K183343 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K153007 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K984759 18291154S Arthrodesis Nail, RIGHT ¿11.5 x 540mm K972226 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K169101 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K154907 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K140784 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K482337 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K264256 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K739432 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K931618 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K144840 18291158S Arthrodesis Nail, RIGHT ¿11.5 x 580mm K109854 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K923722 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K395490 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K114993 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K252640 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K177754 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K149931 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K250372 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K138344 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K129743 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K409129 18291162S Arthrodesis Nail, RIGHT ¿11.5 x 620mm K844007 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K870887 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K109958 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K237890 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K258328 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K923718 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K248395 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K276178 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K276181 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K177755 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K119469 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K190445 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K173143 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K172578 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K124572 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K695562 18291166S Arthrodesis Nail, RIGHT ¿11.5 x 660mm K857462 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K177756 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K169979 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K149930 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K253421 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K212596 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K205529 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K194207 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K171314 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K147167 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K132491 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K952957 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K845196 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K710256 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K669610 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K412352 18291170S Arthrodesis Nail, RIGHT ¿11.5 x 700mm K984763 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K394348 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K395492 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K890909 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K218356 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K206748 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K181988 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K119468 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K250371 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K171315 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K154906 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K138347 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K126931 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K822867 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K941271 18291174S Arthrodesis Nail, RIGHT ¿11.5 x 740mm K879170 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K739428 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K113093 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K843328 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K299898 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K289452 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K207160 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K292169 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K257592 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K181110 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K175468 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K133244 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K679111 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K668032 18291178S Arthrodesis Nail, RIGHT ¿11.5 x 780mm K468440 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K179514 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K395494 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K156526 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K210495 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K250369 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K129744 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K516239 18291304S Arthrodesis Nail, LEFT ¿13 x 540mm K800545 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K634948 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K793958 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K252647 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K189054 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K144182 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K125513 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K675653 18291308S Arthrodesis Nail, LEFT ¿13 x 580mm K857464 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K912208 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K395493 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K156527 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K140297 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K196993 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K250368 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K131411 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K571140 18291312S Arthrodesis Nail, LEFT ¿13 x 620mm K486579 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K168867 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K739423 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K285913 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K273150 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K153006 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K150826 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K144179 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K130898 18291316S Arthrodesis Nail, LEFT ¿13 x 660mm K941225 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K105555 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K291225 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K923684 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K739419 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K156548 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K252654 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K210491 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K172102 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K219680 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K185072 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K205385 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K133245 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K125510 18291320S Arthrodesis Nail, LEFT ¿13 x 700mm K857465 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K634950 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K739402 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K395495 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K890911 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K152098 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K271360 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K250367 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K219681 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K294123 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K259501 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K191811 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K159668 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K130899 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K858123 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K996615 18291324S Arthrodesis Nail, LEFT ¿13 x 740mm K971900 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K219682 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K174621 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K154903 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K154905 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K129034 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K822870 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K436720 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K552012 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K923681 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K579494 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K395496 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K669017 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K847903 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K125016 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K259581 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K243245 18291328S Arthrodesis Nail, LEFT ¿13 x 780mm K196994 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K919062 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K115012 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K250366 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K216821 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K171316 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K138297 18291354S Arthrodesis Nail, RIGHT ¿13 x 540mm K941224 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K291250 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K847916 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K128683 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K189317 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K271359 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K221116 18291358S Arthrodesis Nail, RIGHT ¿13 x 580mm K154902 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K739401 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K395497 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K115013 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K125017 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K153004 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K125514 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K443306 18291362S Arthrodesis Nail, RIGHT ¿13 x 620mm K406131 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K579495 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K210490 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K144570 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K221117 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K171317 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K529708 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K946483 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K404269 18291366S Arthrodesis Nail, RIGHT ¿13 x 660mm K992981 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K928331 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K739400 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K152096 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K250360 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K273151 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K171318 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K137346 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K128493 18291370S Arthrodesis Nail, RIGHT ¿13 x 700mm K946729 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K390804 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K213835 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K890912 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K266892 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K210489 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K253420 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K219683 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K171320 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K174509 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K675584 18291374S Arthrodesis Nail, RIGHT ¿13 x 740mm K913150 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K389587 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K156617 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K126213 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K289453 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K229364 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K153857 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K144568 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K182395 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K138350 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K129745 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K699574 18291378S Arthrodesis Nail, RIGHT ¿13 x 780mm K834177 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K129746 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K965758 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K397975 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K579496 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K209125 18292004S Arthrodesis Nail, LEFT ¿10 x 540mm K145057 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K264254 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K160401 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K147168 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K129747 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K133232 18292008S Arthrodesis Nail, LEFT ¿10 x 580mm K106063 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K634952 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K579497 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K177757 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K153001 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K141826 18292012S Arthrodesis Nail, LEFT ¿10 x 620mm K491099 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K634953 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K890913 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K252669 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K119461 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K292168 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K154897 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K137366 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K129748 18292016S Arthrodesis Nail, LEFT ¿10 x 660mm K667684 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K634956 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K579498 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K285336 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K149932 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K259500 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K188418 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K133243 18292020S Arthrodesis Nail, LEFT ¿10 x 700mm K491120 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K862866 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K168869 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K560636 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K250355 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K157207 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K152999 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K133235 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K128495 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K521105 18292024S Arthrodesis Nail, LEFT ¿10 x 740mm K401749 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K923677 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K579500 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K115014 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K189316 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K189984 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K154893 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K133239 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K965755 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K491139 18292028S Arthrodesis Nail, LEFT ¿10 x 780mm K491122 18292054S Arthrodesis Nail, RIGHT ¿10 x 540mm K268178 18292054S Arthrodesis Nail, RIGHT ¿10 x 540mm K177765 18292054S Arthrodesis Nail, RIGHT ¿10 x 540mm K164343 18292054S Arthrodesis Nail, RIGHT ¿10 x 540mm K140921 18292054S Arthrodesis Nail, RIGHT ¿10 x 540mm K999260 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K293137 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K152996 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K888605 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K719553 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K140295 18292058S Arthrodesis Nail, RIGHT ¿10 x 580mm K215572 18292062S Arthrodesis Nail, RIGHT ¿10 x 620mm K291229 18292062S Arthrodesis Nail, RIGHT ¿10 x 620mm K201189 18292062S Arthrodesis Nail, RIGHT ¿10 x 620mm K152995 18292062S Arthrodesis Nail, RIGHT ¿10 x 620mm K898086 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K115015 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K189315 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K117497 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K175470 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K140785 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K129749 18292066S Arthrodesis Nail, RIGHT ¿10 x 660mm K409066 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K153831 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K117498 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K190231 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K171319 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K154892 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K138301 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K102534 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K491147 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K881487 18292070S Arthrodesis Nail, RIGHT ¿10 x 700mm K491145 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K719554 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K634957 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K556940 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K210488 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K177412 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K154891 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K140782 18292074S Arthrodesis Nail, RIGHT ¿10 x 740mm K491186 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K284438 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K113085 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K115016 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K285337 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K177766 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K152994 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K947269 18292078S Arthrodesis Nail, RIGHT ¿10 x 780mm K767260 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
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For Additional Information Contact | Ms. Colleen O'Meara 201-831-5970 |
Manufacturer Reason for Recall | Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. |
FDA Determined Cause 2 | Packaging |
Action | Stryker Orthopaedics sent Recall letters/Customer Response forms dated 1/26/2012 and 1/30/2012 on 1/27/2012 and 1/31/2012 via FEDEX to their branches, hospitals and surgeon accounts respectively. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to contact their Stryker representative to arrange for return of any affected product. Customers were asked to fax back the attached Product Recall Acknowledgment Form as soon as possible to 201-831-6069..
For any questions customers should call 201-972-2100.
For questions regarding this recall 201-831-5970. |
Quantity in Commerce | 532 units. |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HSB
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