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RecallWatchMedical Device Safety
Class IIOngoingZ-0230-2026

CPM Medical Consultants, LLC. recalls Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400

CPM Medical Consultants, LLC.Farmers Branch, TX, United StatesReported Oct 29, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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, R42260XSLR42260XSR
    UDI-DI B565OS200020L
    221 affected lots
    2025/09/10B565OS200020LB565OS200025LB565OS200120LB565OS200125B565OS200125LB565OS200135B565OS200324
    +213 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

What the firm is doing

On 9/17/2025, correction notices were mailed to customers and distributors who were informed of the following: - The only sterilization requirement now shown on the new Rev D IFU is 4 mins exposure time at 132-Degrees C (270-Degrees F) and 20-30mins drying time. - All affected versions of the IFU should be immediately discarded. - You can access the e-IFU at: https://fusemedical.com/wp-content/uploads/2025/09/Fuse-ULTRA-Foot-Plating-System-IFU-Rev-D-9.2025.pdf - Please pass on this Medical Device Correction to all users of the products and all other people who need to be aware within your organization. - If you have or may have distributed the products listed, please identify and promptly notify those recipients with a copy of this notice, response form, and updated IFU. - Complete and return the response form via email to FMohammad@FuseMedical.com If you have any questions, contact the firm at info@fusemedical.com

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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