[pending] Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS2000
Pending LLM rewrite. Source: FDA_DEVICE Z-0230-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- 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, O
- Manufacturer
- CPM Medical Consultants, LLC.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- B565OS200025L
- B565OS200120L
- B565OS200125
- B565OS200125L
- B565OS200135
- B565OS200324
- B565OS200325
- B565OS200326
- B565OS200400
- B565OS200401
- B565OS200516
- B565OS200518
- B565OS200520
- B565OS200522
- B565OS200616
- B565OS200618
- B565OS200620
- B565OS200622
- B565OS216150
- B565OS218150
Distribution
Distributed nationwide across the United States.
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