Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
This recall has been terminated (originally issued March 11, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- January 27, 2014
- Posted
- March 11, 2014
- Terminated
- August 26, 2016
- Recall Number
- Z-1174-2014
- Quantity
- 18747
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
Distribution
USA Nationwide Distribution
Lot / Code Info
All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.
Root Cause
Labeling design
Action Taken
Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. .