Surgical Head Fixation Device Mount Clamp Assembly Deflection Recall
Deerfield Imaging recalls the Trumpf Mount Clamp Assembly component used in surgical head fixation devices. The clamp may deflect during use and become difficult to loosen after procedures, potentially requiring surgical intervention.
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: This FDA Class II recall involves a surgical positioning device with reports of mechanical deflection. While the potential consequences (surgical intervention, extended anesthesia, ergonomic injury) are significant, the source text does not report any actual patient injuries or hospitalizations. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
Deerfield Imaging, Inc. is recalling the Trumpf Mount Clamp Assembly (part #118704-000), a component of the IMRIS HFD100 head fixation device. The device is used with ORT400 operating room tables and is distributed in nine U.S. states (Alabama, Florida, Georgia, Massachusetts, Minnesota, North Carolina, New York, Ohio, and Texas), as well as Sweden and Switzerland. A total of 24 units with specific serial numbers have been identified in this recall.
The company has received reports that the split block clamp may deflect rotationally when normal lateral forces are applied during surgical procedures. After deflection, the clamp may not return to its proper position. In response to this deflection issue, some users have tightened the hand knob screw excessively, which makes the component difficult to untighten afterward.
If the clamp remains deflected without being noticed, the head fixation device could shift position undetected during surgery. This could result in the need for surgical intervention, require reestablishing navigation systems, or extend the patient's time under anesthesia. Additionally, the difficulty in loosening the component after use may cause ergonomic injury to staff or necessitate workarounds during equipment teardown.
The recalled product
- Product
- Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
- Manufacturer
- Deerfield Imaging, Inc.
- Hazard
- mechanical-deflection
- difficult-loosening
- ergonomic-injury
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)
- 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
Distribution
Distributed nationwide across the United States.
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