FDA Recalls & Safety Alerts - The Conscious Plate

Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, OS200518, OS200520, OS200522, OS200616, OS200618, OS200620, OS200622, OS421300, OS421302, OS421304, OS421306, OS421308, OS421208, OS421210, OS421212, OS421000L, OS421000R, OS421002L, OS421002R, OS421004L, OS421004R, OS421006L, OS421006R, OS42260LL, OS42260LR, OS42260ML, OS42260MR, OS42260SL, OS42260SR, OS42260XSL, OS42260XSR, OS422800, OS422803, OS422804, OS422805, OS422807, OS422825, OS422400, OS422403, OS422404, OS422405, OS422406, OS422407, OS421406, OS421408, OS421414, OS422702, OS422703, OS422712, OS422714, OS422716, OS421512, OS421514, OS421516, OS421112, OS421116, OS421120, OS421124, OS421130, OS42150L, OS42150M, OS42150S, OS42150XS, OS326920-T, OS326922-T, OS326924-T, OS326925, OS326925-T, OS326926-T, OS326928, OS326928-T, OS326930, OS326930-T, OS326932, OS326932-T, OS326934, OS326934-T, OS326936, OS326936-T, OS326938, OS326938-T, OS326940, OS326940-T, OS326945, OS326945-T, OS326950, OS326950-T, OS326955, OS326955-T, OS326960, OS326960-T, OS327920, OS327922, OS327924, OS327926, OS327928, OS327930, OS327932, OS327934, OS327936, OS327938, OS327940, OS327945, OS327950, OS327955, OS327960, OS421710, OS421712, OS421714, OS421716, OS421718, OS421720, OS421722, OS421724, OS421726, OS421728, OS421730, OS421735, OS421740, OS421745, OS421750, OS422508, OS422510, OS422512, OS422514, OS422516, OS422518, OS422520, OS422522, OS422524, OS422526, OS422528, OS422530, OS421814, OS421816, OS421818, OS421820, OS421822, OS421824, OS421826, OS421828, OS421830, OS421835, OS421840, OS421845, OS421850, OS422608, OS422610, OS422612, OS422614, OS422616, OS422618, OS422620, OS422622, OS422624, OS422626, OS422628, OS422630, R327924, R327928, R327932, R327936, R327940, R327945, R327950, R421000L, R421000R, R421710, R421712, R421714, R421716, R421718, R421720, R421722, R421724, R421726, R421728, R421730, R421735, R421740, R421814, R421816, R421818, R421820, R421822, R421824, R421826, R421828, R421830, R421835, R421840, R421845, R421850, R42260ML, R42260MR, R42260SL, R42260SR, R42260XSL, R42260XSR Class II

Reason: Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.

CPM Medical Consultants, LLC. 20250917 Ongoing

Distributed: US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.

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LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. Class II

Reason: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Synthes (USA) Products LLC 20250926 Ongoing

Distributed: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.

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LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. Class II

Synthes (USA) Products LLC 20250926 Ongoing

Distributed: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.

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iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm Class II

Reason: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

Theken Companies LLC 20250911 Ongoing

Distributed: US Nationwide distribution in the states of NJ, PA, and TX.

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One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. Class III

Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Home Health US, Incorporated 20250725 Ongoing

Distributed: U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A

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Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only Class II

Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.