Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1174-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 27, 2014

Date Posted: March 19, 2014

Recall Number: Z-1174-2014

Event ID: 67391

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.

Status: Terminated

Product Quantity: 18747

Code Information:

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.

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated