Synthes, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1514-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.

Product Classification:

Class II

Date Initiated: March 19, 2018

Date Posted: May 2, 2018

Recall Number: Z-1514-2018

Event ID: 79698

Reason for Recall:

There is a potential for the connection screw of the stem extractor to break.

Status: Terminated

Product Quantity: 31

Code Information:

09-6793, 10-2637, 10-5070, 12-2707, 14-1085, 15-8949

Distribution Pattern:

Worldwide Distribution: US (nationwide) and to countries of: Canada and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated