Z-2772-2015 Class II Terminated
FDA device recall Z-2772-2015 was initiated by Orthovita, Inc., dBA Stryker Orthobiologics. on August 20, 2015 and is designated Class II. Reason for recall: Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration The recall status is terminated (terminated March 10, 2017). Affected quantity: 9805.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2015
- Initiation Date
- August 20, 2015
- Termination Date
- March 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9805
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
Reason for Recall
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
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.
Code Information
All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505