Trumpf Mount Clamp Assembly recall
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and…
Why was Trumpf Mount Clamp Assembly recalled?
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model #119629-000, UDI 00857534006592; and model #119630-000, UDI 00857534006615. Serial numbers: 10008164, 10007550, 10007555, 10008864, 10008160, 10008161, 10008859, 10008860, 10010668, 10010669, 10010673, 10010674, 10010672, 10007556, 10007557, 10008862, 10008861, 10008158, 10008159, 10008863, 10008165, 10007558, 10008865, and 10010675.
- Product
- Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and…
- Recalling firm
- Deerfield Imaging, Inc.
- Quantity
- 24
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, FL, GA, MA, MN, NC, NY, OH, and TX. The countries of Sweden and Switzerland.
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)