--- title: "Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw... — FDA record Z-0768-2023 | Is It on Recall" description: "Distribution without Pre-Market Clearance" url: https://isitonrecall.com/recall/fda-device-z-0768-2023-acutrak-2-part-number-part-description-30-0021-25-0mm-acutrak-2-5-5-screw-30-0021-s-25-0mm-acutrak-2/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw... — FDA record Z-0768-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Nov 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Acutrak 2¿ - 5.5 Screw 30-0084 55.0mm Acutrak 2¿ - 5.5 Screw 30-0084-S 55.0mm Acutrak 2¿ - 5.5 Screw 30-0085 60.0mm Acutrak 2¿ - 5.5 Screw 30-0085-S 60.0mm Acutrak 2¿ - 5.5 Screw 30-0620 20.0mm Acutrak 2¿ - 4.7 Screw 30-0620-S 20.0mm Acutrak 2¿ - 4.7 Screw 30-0622 22.0mm Acutrak 2¿ - 4.7 Screw 30-0622-S 22.0mm Acutrak 2¿ - 4.7 Screw 30-0624 24.0mm Acutrak 2¿ - 4.7 Screw 30-0624-S 24.0mm Acutrak 2¿ - 4.7 Screw 30-0626 26.0mm Acutrak 2¿ - 4.7 Screw 30-0626-S 26.0mm Acutrak 2¿ - 4.7 Screw 30-0628 28.0mm Acutrak 2¿ - 4.7 Screw 30-0628-S 28.0mm Acutrak 2¿ - 4.7 Screw 30-0630 30.0mm Acutrak 2¿ - 4.7 Screw 30-0630-S 30.0mm Acutrak 2¿ - 4.7 Screw 30-0635 35.0mm Acutrak 2¿ - 4.7 Screw 30-0635-S 35.0mm Acutrak 2¿ - 4.7 Screw 30-0640 40.0mm Acutrak 2¿ - 4.7 Screw 30-0640-S 40.0mm Acutrak 2¿ - 4.7 Screw 30-0645 45.0mm Acutrak 2¿ - 4.7 Screw 30-0645-S 45.0mm Acutrak 2¿ - 4.7 Screw 30-0650 50.0mm Acutrak 2¿ - 4.7 Screw 30-0650-S 50.0mm Acutrak 2¿ - 4.7 Screw 30-0740 40.0mm Acutrak 2¿ - 7.5 Screw 30-0740-S 40.0mm Acutrak 2¿ - 7.5 Screw 30-0745 45.0mm Acutrak 2¿ - 7.5 Screw 30-0745-S 45.0mm Acutrak 2¿ - 7.5 Screw 30-0750 50.0mm Acutrak 2¿ - 7.5 Screw 30-0750-S 50.0mm Acutrak 2¿ - 7.5 Screw 30-0755 55.0mm Acutrak 2¿ - 7.5 Screw 30-0755-S 55.0mm Acutrak 2¿ - 7.5 Screw 30-0760 60.0mm Acutrak 2¿ - 7.5 Screw 30-0760-S 60.0mm Acutrak 2¿ - 7.5 Screw 30-0770 70.0mm Acutrak 2¿ - 7.5 Screw 30-0770-S 70.0mm Acutrak 2¿ - 7.5 Screw 30-0775 75.0mm Acutrak 2¿ - 7.5 Screw 30-0775-S 75.0mm Acutrak 2¿ - 7.5 Screw 30-0780 80.0mm Acutrak 2¿ - 7.5 Screw 30-0780-S 80.0mm Acutrak 2¿ - 7.5 Screw 30-0785 85.0mm Acutrak 2¿ - 7.5 Screw 30-0785-S 85.0mm Acutrak 2¿ - 7.5 Screw 30-0790 90.0mm Acutrak 2¿ - 7.5 Screw 30-0790-S 90.0mm Acutrak 2¿ - 7.5 Screw 30-0795 95.0mm Acutrak 2¿ - 7.5 Screw 30-0795-S 95.0mm Acutrak 2¿ - 7.5 Screw 30-0800 100.0mm Acutrak 2¿ - 7.5 Screw 30-0800-S 100.0mm Acutrak 2¿ - 7.5 Screw 30-0805 105.0mm Acutrak 2¿ - 7.5 Screw 30-0805-S 105.0mm Acutrak 2¿ - 7.5 Screw 30-0810 110.0mm Acutrak 2¿ - 7.5 Screw 30-0810-S 110.0mm Acutrak 2¿ - 7.5 Screw 30-0815 115.0mm Acutrak 2¿ - 7.5 Screw 30-0815-S 115.0mm Acutrak 2¿ - 7.5 Screw 30-0820 120.0mm Acutrak 2¿ - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2¿ Bone Screw - **Reason**: Distribution without Pre-Market Clearance - **Classification**: Class II - **Recalling firm**: Acumed LLC - **Quantity**: 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0768-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0768-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Acutrak 2 Fusion Device Batch Number/Part Number/Part Description/UDI Code: W74030 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-W74030000000 204349 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-204349000000 207092 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207092000000 208497 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208497000000 207877 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207877000000 208095 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208095000000 209948 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-209948000000 210146 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210146000000 212410 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212410000000 210147 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210147000000 214004 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-214004000000 212916 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212916000000 215249 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-215249000000 216130 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-216130000000 269589 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-269589000000 273212 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-273212000000 275237 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-275237000000 279567 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-279567000000 280672 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-280672000000 286762 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-286762000000 292375 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-292375000000 297811 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-297811000000 298112 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-298112000000 301151 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-301151000000 300366 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-300366000000 302325 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-302325000000 350026 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-350026000000 356311 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-356311000000 377077 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-377077000000 401842 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-401842170130 423327 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-423327171110 428018 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-428018171228 459563 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-459563190114 469615 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-469615190429 477574 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-477574190813 484366 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-484366191107 514186 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-514186201121 526705 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-526705210422 210529 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210529000000160630 210839 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210839000000160630 210530 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210530000000160630 210531 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210531000000160630 210603 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210603000000160630 210889 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-210889000000160630 214219 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-214219000000160830 214220 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-214220000000160830 214467 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-214467000000160831 214468 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-214468000000160831 224822 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-224822000000 225047 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-225047000000 261993 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-261993000000181130 276446 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-276446000000190731 282207 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-282207000000190831 294525 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-294525000000200228 298257 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-298257000000200430 311308 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-311308000000201031 314283 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-314283000000201130 315745 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-315745000000201231 359591 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-359591000000220731 359981 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-359981000000220831 383212 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-383212160527230527 391829 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-391829160822230822 401087 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-401087161219231219 421803 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-421803170915240914 427724 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-427724171130241129 441547 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-441547180510250509 446005 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-446005180711250710 455459 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-455459181115251114 458560 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-458560190102260101 466606 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-466606190326260325 467769 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-467769190409260408 474836 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-474836190710260709 473246 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-473246190617260616 496039 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-496039200324270324 512338 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-512338201027271027 536116 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-536116210726280725 547375 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015373-547375211028281027 W74031 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-W74031000000 205404 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-205404000000 207093 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-207093000000 207875 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-207875000000 208496 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-208496000000 208096 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-208096000000 209949 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-209949000000 210221 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-210221000000 210223 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-210223000000 212918 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-212918000000 214003 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-214003000000 215250 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-215250000000 273213 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-273213000000 275238 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-275238000000 279568 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-279568000000 280673 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-280673000000 292376 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-292376000000 298280 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-298280000000 297870 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-297870000000 300367 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-300367000000 302326 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-302326000000 311415 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-311415000000 315852 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-315852000000 356312 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-356312000000 377078 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-377078000000 382257 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-382257000000 392562 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-392562160923 414690 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-414690170714 416824 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-416824170814 423328 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-423328171030 428019 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-428019171228 438779 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-438779180430 465278 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-465278190312 469616 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-469616190429 477575 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-477575190813 484367 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-484367191107 492152 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-492152200213 521548 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-521548210304 526706 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-526706210422 549509 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-549509211129 566382 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015403-566382220618 210614 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210614000000160630 210617 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210617000000160630 210840 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210840000000160630 210612 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210612000000160630 210620 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210620000000160630 210890 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-210890000000160630 211168 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-211168000000160630 214221 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-214221000000160830 214469 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-214469000000160831 214470 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-214470000000160831 246139 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-246139000000180131 276447 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-276447000000190731 299407 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-299407000000200430 309170 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-309170000000200930 310664 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-310664000000201031 311309 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-311309000000201031 315192 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-315192000000201231 315746 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-315746000000201231 319134 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-319134000000210228 333889 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-333889000000210831 356270 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-356270000000220630 359592 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-359592000000220731 359982 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-359982000000220831 371761 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-371761151218221217 375603 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-375603160217230216 381429 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-381429160503230503 383213 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-383213160525230525 386070 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-386070160628230628 390290 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-390290160729230729 391830 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-391830160822230822 401088 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-401088161220231220 412311 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-412311170501240430 414968 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-414968170617240616 418439 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-418439170728240727 427725 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-427725171204241203 435005 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-435005180228250227 438054 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 10806378015410-438054180328250327 446006 30-... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0768-2023%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jan 4, 2023 - **Recall initiation date**: Nov 29, 2022 - **Center classification date**: Dec 23, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0768-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Acumed LLC records](https://isitonrecall.com/brand/acumed-llc/)