FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
- Recall number
- Z-0391-2014
- Recalling firm
- Synthes USA HQ, Inc.
- Product
- Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
- Status
- Terminated
- Initiated
- 2013-06-22
- Posted
- 2013-11-26
- Terminated
- 2015-09-10
- Reason
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 209
- Distribution
- Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
- Lot, serial or model codes
- Parts 03.632.040 and 03.632.041 with various lot nos. Item Lot Number Number 03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995 Item Lot Number Number 03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXP
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28