Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Reported: June 25, 2014 Initiated: April 10, 2014 #Z-1833-2014
Product Description
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Reason for Recall
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 5,114,052
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.. Recalled by Synthes, Inc.. Units affected: 5,114,052.
Why was this product recalled? ▼
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1833-2014.
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