Recall Z-0230-2026 ยท HRS Plate, Fixation, Bone
CPM Medical Consultants, LLC.
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, OS4
| Date | Oct 21, 2025 (initiated Sep 17, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | 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 o |
| Quantity | 3317 |
| Distribution | US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141784 | ORTHO SOLUTIONS ULTOS PLATING SYSTEM Ortho Solutions Limited, Jul 23, 2014 |