Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections
Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly reports one serious injury, which meets the rubric criteria for a score of 4 (Severe) involving significant injury reports.
Plain-English summary
Synthes (USA) Products LLC is recalling the Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis, and Large) due to labeling changes related to MRI conditions. The recall identifies additional part numbers within the system that should be considered MR Conditional to align with standard definitions for MR Safe, MR Conditional, and MR Unsafe.
The affected products are intended to stabilize and treat fractures of small bones, construct external fixation frames for pediatric and adult fractures, and treat long bone and pelvic fractures. The recall covers worldwide distribution, including the United States and Canada. The source text reports one serious injury associated with this recall.
Healthcare providers and patients should verify the part numbers of their external fixation systems against the list provided in the official recall notice. If a device is affected, users should follow the instructions provided by Synthes (USA) Products LLC regarding the corrected MR Conditional status to ensure safe use in MRI environments.
The recalled product
- Product
- Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 5,306,080
Distribution
Distributed nationwide across the United States.
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