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Fuse ULTRA Foot Plating System Instructions for Use recallZ-0230-2026 · CPM Medical Consultants, LLC. · initiated Sep 17, 2025

Class II Open, Classified All recalls posted in October 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CPM Medical Consultants, LLC. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling design

What the company 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 [email protected] If you have any questions, contact the firm at [email protected]

Recall details

Recall number
Z-0230-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 17, 2025
Posted by the FDA
Oct 21, 2025
Recalling firm
CPM Medical Consultants, LLC.
Quantity
3317
Product code
HRS
FDA submissions
K141784
Distribution
US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

All versions of IFU DC-0495 prior to Rev D. All Lots Up to Date 2025/09/10. UDI-DI: B565OS200020L, B565OS200025L, B565OS200120L, B565OS200125, B565OS200125L, B565OS200135, B565OS200324, B565OS200325, B565OS200326, B565OS200400, B565OS200401, B565OS200516, B565OS200518, B565OS200520, B565OS200522, B565OS200616, B565OS200618, B565OS200620, B565OS200622, B565OS216150, B565OS218150, B565OS292110, B565OS292120, B565OS292160, B565OS292200, B565OS326920T, B565OS326922T, B565OS326924T, B565OS326925, B565OS326925T, B565OS326926T, B565OS326928, B565OS326928T, B565OS326930, B565OS326930T, B565OS326932, B565OS326932T, B565OS326934, B565OS326934T, B565OS326936, B565OS326936T, B565OS326938, B565OS326938T, B565OS326940, B565OS326940T, B565OS326945, B565OS326945T, B565OS326950, B565OS326950T, B565OS326955, B565OS326955T, B565OS326960, B565OS326960T, B565OS327920, B565OS327922,B565OS327924, B565OS327926, B565OS327928, B565OS327930, B565OS327932, B565OS327934, B565OS327936, B565OS327938, B565OS327940, B565OS327945, B565OS327950, B565OS327955, B565OS327960, B565OS328017, B565OS328026, B565OS328028C, B565OS421000L, B565OS421000R, B565OS421002L, B565OS421002R, B565OS421004L, B565OS421004R, B565OS421006L, B565OS421006R, B565OS421112, B565OS421116, B565OS421120, B565OS421124, B565OS421130, B565OS421208, B565OS421210, B565OS421212, B565OS421300, B565OS421302, B565OS421304, B565OS421306, B565OS421308, B565OS421406, B565OS421408, B565OS421414, B565OS42150L, B565OS42150M, B565OS42150S, B565OS42150XS, B565OS421512, B565OS421514, B565OS421516, B565OS421710, B565OS421712, B565OS421714, B565OS421716, B565OS421718, B565OS421720, B565OS421722, B565OS421724, B565OS421726, B565OS421728, B565OS421730, B565OS421735, B565OS421740, B565OS421745, B565OS421750, B565OS421814, B565OS421816, B565OS421818, B565OS421820, B565OS421822, B565OS421824, B565OS421826, B565OS421828, B565OS421830, B565OS421835, B565OS421840, B565OS421845, B565OS421850, B565OS422400, B565OS422403, B565OS422404, B565OS422405, B565OS422406, B565OS422407, B565OS422508, B565OS422510, B565OS422512, B565OS422514, B565OS422516, B565OS422518, B565OS422520, B565OS422522, B565OS422524, B565OS422526, B565OS422528, B565OS422530, B565OS422608, B565OS42260LL, B565OS42260LR, B565OS42260ML, B565OS42260MR, B565OS42260SL, B565OS42260SR, B565OS42260XSL, B565OS42260XSR, B565OS422610, B565OS422612, B565OS422614, B565OS422616, B565OS422618, B565OS422620, B565OS422622, B565OS422624, B565OS422626, B565OS422628, B565OS422630, B565OS422702, B565OS422703, B565OS422712, B565OS422714, B565OS422716, B565OS42280, B565OS422803, B565OS422804, B565OS422805, B565OS422807, B565OS422825, B565R327924, B565R327928, B565R327932, B565R327936, B565R327940, B565R327945, B565R327950, B565R421000L, B565R421000R, B565R421710, B565R421712, B565R421714, B565R421716, B565R421718, B565R421720, B565R421722, B565R421724, B565R421726, B565R421728, B565R421730, B565R421735, B565R421740, B565R421814, B565R421816, B565R421818, B565R421820, B565R421822, B565R421824, B565R421826, B565R421828, B565R421830, B565R421835, B565R421840, B565R421845, B565R421850, B565R42260M, B565R42260MR, B565R42260SL, B565R42260SR, B565R42260XSL, B565R42260XSR

Other devices under the same FDA submission

5 devices cleared under K141784 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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