Recall archive / FDA device enforcement
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS20... — FDA record Z-0230-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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, 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
- 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.
- Classification
- Class II
- Recalling firm
- CPM Medical Consultants, LLC.
- Quantity
- 3317
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0230-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Sep 17, 2025
- Center classification date
- Oct 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.