Reported Sep 23, 2015 · Terminated
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone…
Orthovita, Inc., dba Stryker Orthobiologics.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthovita, Inc., dBA Stryker Orthobiologics. · 45 Great Valley Pkwy · Malvern, PA · 19355-1302
Is this the product you have?
- Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
- Lot codes and dates
- All lots
- Model Number of device
2090-05012090-05022090-05042090-0505
- Amount recalled
- 9805
Where it was sold
- Nationwide
Why it was recalled
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
This product could cause temporary or reversible health problems — stop using it.
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