Orthovita, Inc., dBA Stryker Orthobiologics.: Medical Device Recall in 2015 - (Recall #: Z-2772-2015)

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:

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone

Product Classification:

Class II

Date Initiated: August 20, 2015

Date Posted: September 23, 2015

Recall Number: Z-2772-2015

Event ID: 72054

Reason for Recall:

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Status: Terminated

Product Quantity: 9805

Code Information:

All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Distribution Pattern:

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated