Recall Z-2772-2015— Orthovita, Inc., dBA Stryker Orthobiologics.
Class II · Terminated
Class II FDA medical device recall by Orthovita, Inc., dBA Stryker Orthobiologics., initiated 2015-08-20, terminated 2017-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration.
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-20
- Terminated
- 2017-03-10
- Firm location
- Malvern, PA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.