Reported Oct 29, 2025 · Ongoing
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L,…
CPM Medical Consultants, LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CPM Medical Consultants, LLC. · 4343 Sigma Rd Ste 500 · Farmers Branch, TX · 75244-4490
Is this the product you have?
- Fuse ULTRA Foot Plating System Instructions for Use
- Models
220 of 220 codes
OS200400OS200401OS328017OS200020LOS200025LOS200120LOS200125OS200125LOS200135OS200324OS200325OS200326OS328026OS328028COS216150OS218150OS292110OS292120OS292160OS292200OS200516OS200518OS200520OS200522OS200616OS200618OS200620OS200622OS421300OS421302OS421304OS421306OS421308OS421208OS421210OS421212OS421000LOS421000ROS421002LOS421002ROS421004LOS421004ROS421006LOS421006ROS42260LLOS42260LROS42260MLOS42260MROS42260SLOS42260SROS42260XSLOS42260XSROS422800OS422803OS422804OS422805OS422807OS422825OS422400OS422403
- Lot codes and dates
- All versions of IFU DC-0495 prior to Rev D. All Lots Up to Date 2025/09/10
- UDI-DI
220 of 220 codes
B565OS200020LB565OS200025LB565OS200120LB565OS200125B565OS200125LB565OS200135B565OS200324B565OS200325B565OS200326B565OS200400B565OS200401B565OS200516B565OS200518B565OS200520B565OS200522B565OS200616B565OS200618B565OS200620B565OS200622B565OS216150B565OS218150B565OS292110B565OS292120B565OS292160B565OS292200B565OS326920TB565OS326922TB565OS326924TB565OS326925B565OS326925TB565OS326926TB565OS326928B565OS326928TB565OS326930B565OS326930TB565OS326932B565OS326932TB565OS326934B565OS326934TB565OS326936B565OS326936TB565OS326938B565OS326938TB565OS326940B565OS326940TB565OS326945B565OS326945TB565OS326950B565OS326950TB565OS326955B565OS326955TB565OS326960B565OS326960TB565OS327920B565OS327922B565OS327924B565OS327926B565OS327928B565OS327930B565OS327932
- Amount recalled
- 3317
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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