{ "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": "West Chester", "state": "PA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71976", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "address_2": "N/A", "postal_code": "19380-5986", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Nationwide Distribution", "recall_number": "Z-2794-2015", "product_description": "Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.", "product_quantity": "40038", "reason_for_recall": "DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.", "recall_initiation_date": "20150811", "center_classification_date": "20150918", "termination_date": "20160818", "report_date": "20150930", "code_info": "Part Numbers 09.213.022S 09.213.024S 09.213.026S 09.213.028S 09.213.030S 09.213.032S 09.213.034S 09.213.036S 09.213.038S 09.213.040S 09.213.042S 09.213.044S 09.213.046S 09.213.048S 09.213.050S 09.213.052S 09.213.054S 09.213.056S 09.213.058S 09.213.060S 09.213.065S 09.213.070S 09.223.032S 09.223.034S 09.223.036S 09.223.038S 09.223.040S 09.223.042S 09.223.044S 09.223.046S 09.223.048S 09.223.050S 09.223.055S 09.223.060S 09.223.065S 09.223.070S 09.223.075S 09.223.080S 09.223.085S 09.223.090S with Lot Numbers 2799588 2799590 2801042 2801043 2802483 2803970 2806031 2809073 2809673 2812544 2813042 2813043 2813065 2814722 2815303 2822441 2822442 7802259 7802261 7804003 7813305 7833918 7883446 2799592 2799804 2801040 2801041 2802484 2803971 2806032 2809075 2809668 2809669 2810870 2810896 2811588 2814723 2815305 2822443 7764728 7769461 7802262 7804004 7804005 7813306 2798572 2798573 2798574 2801019 2803150 2803361 2804799 2809077 2810267 2810268 2814724 2814725 2815307 2815308 2815837 2815838 2815840 2822033 2826534 7801003 7802263 7813307 7824108 7833920 7865322 7913562 8002399 2798708 2801020 2801021 2802485 2803145 2806033 2809078 2809079 2812546 2812547 2813044 2813045 2813770 2818115 2818116 2822034 2822836 2826536 7801004 7813309 7821406 7824110 7833922 7873469 7913565 2798709 2798710 2798711 2801044 2802481 2803151 2809311 2809312 2812548 2812549 2815841 2815842 2815843 2815844 2826537 2826538 7801006 7813311 7824111 7833923 7833926 7913568 7913570 8002411 2798713 2801022 2803152 2803362 2803363 2809313 2809314 2809664 2809665 2812832 2813046 2813047 2813761 2813763 2814733 2815312 2822035 2822036 2826540 7801012 7813313 7824112 7833929 7833930 7873486 2798715 2801023 2803153 2803364 2806034 2806035 2809317 2809318 2813048 2813049 2813064 2813771 2814736 2814738 2815313 2815315 7801017 7804006 7813314 7824113 7833932 7913572 7913578 2798240 2798717 2798718 2798719 2801024 2803365 2806036 2806037 2809666 2809667 2813050 2813063 2813756 2813757 2813766 2814739 2815317 2815318 2826541 7802266 7806983 7813315 7833933 7865323 7873470 7873471 2798720 2801025 2801026 2803366 2806038 2810269 2810270 2810271 2810273 2813051 2813776 2814741 2815319 2818117 2818606 2822838 2826544 2826824 2826825 7806984 7813317 7824114 7833937 7833948 7833949 7913637 7913641 2798721 2799594 2801027 2803367 2803368 2806039 2806040 2810329 2810331 2813052 2813053 2813758 2813760 2814746 2814751 2815320 2815321 7802282 7802284 7806985 7806986 7813319 7833975 7833976 8002499 8272594 2798722 2798723 2799757 2801028 2801029 2803369 2803963 2808549 2810335 2810336 2810338 2812833 2813054 2813773 2813774 2814753 2815323 2826826 2826827 2826833 2826834 7726601 7726608 7802285 7804017 7813320 7833978 7833979 7873476 2799600 2801030 2801031 2803370 2803964 2804127 2806324 2806325 2810333 2810873 2811586 2813055 2813769 2814758 2818607 2822038 2822039 7801020 7804007 7813333 7824115 7824116 7833982 7873474 7873475 7913647 2799601 2799602 2801032 2803965 2803966 2806557 2806558 2810341 2810342 2812552 2812553 2813056 2813057 2813775 2814760 2815324 2822040 2822044 2826828 2826835 2826836 7804018 7813335 7824149 7833990 7913650 7913652 2799604 2801033 2803967 2803968 2810357 2810358 2810874 2810875 2812554 2812555 2814762 2814765 2814768 2814771 2815325 2819164 2819165 2826070 2826074 2826829 7806987 7806988 7813336 7834028 7913654 2798241 2799612 2801034 2802486 2804114 2808552 2809678 2809679 2810876 2812834 2813058 2813059 2813767 2814775 2815327 2822045 2822047 2826830 7802267 7802286 7806989 7813338 7824171 7834030 8002518 2800599 2801049 2801050 2802487 2806559 2809676 2809677 2810877 2811585 2819441 2826961 2826962 7726611 7782982 7802269 7804019 7813340 7826591 7834032 7834036 7913659 2800600 2802489 2804117 2804796 2809674 2809675 2810878 2813060 2819442 2826963 2826964 7726600 7782986 7782991 7802271 7804020 7813341 7834039 7836176 7836187 2800344 2802491 2802493 2804794 2809321 2810881 2810884 2810885 2813061 2826965 2826966 7782999 7783025 7802273 7804022 7813342 7836192 7836196 7836197 2800212 2802497 2802499 2804795 2810351 2810352 2810886 2810887 2810888 2813062 2826967 2826968 7726597 7726598 7783001 7801023 7806992 7813343 7836202 7836203 7836205 2799618 2801035 2804120 2804121 2804122 2804797 2810346 2810349 2810889 2810890 2812558 2812559 2813765 2814779 2815328 2815329 2822842 2822843 7802275 7806993 7806994 7813344 7836206 2799624 2799625 2801037 2802479 2804123 2809323 2809671 2809672 2810891 2810892 2812557 2815846 2815847 2815848 2815854 2822845 2822846 2826116 2826831 2826832 7804023 7813345 7824185 7836209 7873487 2799627 2799628 2801038 2801039 2804124 2804125 2804126 2804798 2809076 2809670 2810894 2810895 2812556 2813772 2815856 2815857 2815859 2815860 2822834 2822835 2822847 2822848 7811121 7811123 7813346 7836212 8002558 2783396 2783400 2786423 2792364 2795771 2795772 2804548 2805858 2805859 2807688 2807958 2815391 2815398 2818615 2818616 7721840 7721842 7754361 7816040 7816042 7849731 7849737 7913664 7913666 8002613 8002634 8349755 2783409 2783410 2786422 2792365 2795773 2795774 2804790 2807686 2807957 2808519 7722969 7722970 7722972 7755834 7755841 7755842 7781880 7814755 7816046 7816048 7913668 8002641 8002676 8271810 8349753 2778498 2778507 2778508 2783411 2783412 2786283 2792366 2793483 2795794 2804549 2807584 2807949 2815401 2819272 7722974 7722975 7722976 7755844 7761452 7814756 7816057 7816061 7849743 7913670 8002695 8002722 8002739 8271806 8349732 2748748 2749819 2778519 2792345 2793484 2804550 2804791 2804792 2805854 2805855 2807707 2811193 2815434 7722977 7740994 7759402 7759405 7803748 7806668 7807460 7811025 7849752 7849765 7849770 7868979 8002751 8271793 8271802 8340641 8340649 2748939 2749820 2778525 2778526 2778527 2792346 2793485 2795797 2805875 2805877 2805879 2805880 2807946 2808517 2811194 2818618 2818619 2826596 2826597 2826614 7719280 7803749 7807463 7811027 7826551 7833561 7849795 7849799 7849806 7868980 8271784 2748940 2749821 2786424 2786428 2792348 2795803 2804552 2804553 2805881 2805882 2807953 2807954 2808520 2815429 2815430 2826598 2826859 7806671 7807467 7811038 7826553 7849814 7849823 7868981 8340633 2763692 2763694 2773533 2778903 2792349 2793486 2795804 2804554 2806328 2806329 2806633 2807679 2819273 2826599 7754370 7759412 7806673 7807468 7811041 7826554 7913671 7913672 8340619 2749825 2773534 2778906 2778907 2792350 2793487 2795806 2806625 2807499 2807947 2826600 2826601 7740995 7754412 7777726 7803753 7807472 7811043 7833564 7864139 7913673 8002757 2748943 2748945 2773536 2792351 2793488 2795807 2805884 2806623 2806626 2807503 2807684 2807948 2826878 7719553 7719632 7754416 7806674 7807474 7811047 7826555 7864142 7913798 8002775 2748947 2749827 2778910 2778911 2792352 2793489 2795815 2804556 2807694 2807955 2822435 2822436 2826880 7719551 7806676 7807478 7811050 7826557 7833567 7833570 7913800 7913802 8002794 2748971 2749829 2773539 2782704 2782705 2792353 2793490 2795840 2804558 2806632 2807677 2807956 2808522 2819275 7806679 7807482 7811052 7849972 7851114 7851116 7864145 2748972 2749831 2778912 2778913 2778915 2786425 2786431 2792354 2793491 2806624 2806630 2807652 2807691 2819276 7759415 7767363 7807487 7811066 7826560 7826561 7868982 2748973 2751623 2780629 2780630 2792355 2793493 2804559 2806634 2807680 2815431 7719577 7719670 7740996 7740997 7759417 7803754 7806682 7807493 7811071 7833573 2748974 2751624 2792356 2793482 2795847 2804560 2804793 2806629 2807670 2807950 2811195 2818127 2818128 2826603 2826608 2826616 7807500 7811074 7826564 7826571 7833575 7851120 7868985 2748975 2751625 2780632 2782706 2792357 2792358 2795848 2795849 2795850 2806628 2807673 2807951 2807952 2808523 2818621 2819277 7759418 7803755 7803756 7806685 7807503 7811111 7851126 2748976 2751626 2780633 2786427 2792359 2793496 2795851 2804562 2807696 2807959 2818622 2818623 2818624 2826604 2826607 2826618 2826619 2826620 7754421 7754469 7754473 7806688 7807505 7811112 7824208 7851129 2748977 2751632 2774564 2792360 2792361 2793498 2795853 2805895 2805898 2806631 2807676 2807700 2819278 2826605 2826606 2826621 7754428 7754435 7754439 7754440 7806694 7806696 7811113 7826573 8002802 2748978 2774563 2780637 2792362 2792363 2793499 2795855 2804563 2806627 2806635 2807682 2807683 2822430 2822431 2822433 2822434 7754443 7754444 7806698 7806701 7811114 7824213 7833578 7913810" } ] }