—#122360

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.

FDA product code: HXP — Instrument, Bending Or Contouring
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.

Timeline

Recall initiated: 2013-06-22
Posted by FDA: 2013-11-26
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122360. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.