Class II U.S. Food and Drug Administration

CPM Medical Consultants, LLC. Fuse ULTRA Foot Plating System Instructions for Use recall: Instructions for use for a foot plating system is being updated to remove

Recall published 12 months ago

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.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0230-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CPM Medical Consultants, LLC.
Product type
Medical devices
Units affected
3317
Distribution
Nationwide
Made in
United States
Lot / code info
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 covered by this recall

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

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 09
  • 10. UDI-DI

Model or item number

On the rating label, the box or the instruction sheet.

  • OS200400
  • OS200401
  • OS328017
  • OS200020L
  • OS200025L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

CPM Medical Consultants, LLC. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: CPM Medical Consultants, LLC. — 4343 Sigma Rd Ste 500, Farmers Branch, TX, 75244-4490

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CPM Medical Consultants, LLC. medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 09, 10. UDI-DI; model number OS200400, OS200401, OS328017. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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