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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · mri safety
See all →- HighAD-TECH Spencer Probe Depth Electrode recalled for MRI safety label discrepancy
FDA (Devices) · 2024-10-30
- HighGE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk
FDA (Devices) · 2024-08-14
- HighMR System Software Defect May Cause Implant Overheating During Scanning
FDA (Devices) · 2024-08-14
- HighTitanium Toe Joint Implant Labeling Error: Unvalidated MRI Safety Claims
FDA (Devices) · 2022-03-09
- ModerateBioPro Titanium MPJ Toe Implant Recalled for Incorrect MR Compatibility Labeling
FDA (Devices) · 2022-03-09
Similar recalls
- ModerateSynthes External Fixation Systems Recalled for MR Labeling Changes
FDA (Devices) · 2014-06-25
- ModerateSynthes External Fixation Clamp Recalled for Incorrect MR Safety Labeling
FDA (Devices) · 2012-11-21
- HighSynthes Tensioning Device Recalled Due to Potential Mechanical Failure
FDA (Devices) · 2013-12-04
- ModerateSynthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling
FDA (Devices) · 2015-02-04
- ModerateSynthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert
FDA (Devices) · 2013-08-07
- ModerateSynthes Trauma Nail System Recalled for Potential Outer Pouch Compromise
FDA (Devices) · 2013-09-04