Fuse ULTRA Foot Plating System (CPM Medical) – Sterilization Update (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, OS421
Brand
CPM Medical Consultants, LLC.
Lot Codes / Batch Numbers
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
Products Sold
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
CPM Medical Consultants, LLC. is recalling Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS2000 due to Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes expo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026