CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report

Fuse Ultra Foot Plating System Instructions for Use recalled

CPM Medical Consultants is recalling Fuse Ultra Foot Plating System Instructions for Use, distributed nationwide in the US. The recall was initiated on 17 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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

Quantity recalled3317

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0230-2026
FDA event ID: 97679
Recalling firm: CPM Medical Consultants, Farmers Branch, TX
Classification: Class II
Status: Ongoing
Recall initiated: 17 Sep 2025
FDA classified: 21 Oct 2025
Reported: 29 Oct 2025
Type: Voluntary: Firm initiated
Reason category: Sterility
Device type: Other Medical Devices

Timeline

17 Sep 2025	Recall initiated by company
21 Oct 2025	Classified by FDA	+34 days
29 Oct 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Florida Louisiana Nevada Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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