Stryker Spine: Medical Device Recall in 2015 - (Recall #: Z-0222-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

Product Classification:

Class II

Date Initiated: September 8, 2015

Date Posted: November 11, 2015

Recall Number: Z-0222-2016

Event ID: 72495

Reason for Recall:

The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.

Status: Terminated

Product Quantity: 41 units

Code Information:

Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated