Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are u
FDA device recall Z-0391-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HXP
- Quantity affected
- 209
- Distribution
- Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
- Date initiated
- 2013-06-22
- Date posted
- 2013-11-26
- Date terminated
- 2015-09-10
- Location
- West Chester, PA
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