Reported Jan 14, 2015 · Terminated
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4…
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?
- Stryker Orthobiologics Imbibe Aliquot Needle
- Bone Cement Needle- Model Numbers
2110-0505 Beveled Needle11 gauge x 4 inch 2110-0524 Beveled Needle11 gauge x 6 inch 2110-0506 Diamond Needle11 gauge x 4 inch 2110-0529 Diamond Needle11
- gauge x 6 inch Intended UseCan be used in either direct (or open) and percutaneous (or deep) delivery of bone cement
- Lot codes and dates
- all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
- Amount recalled
- 2155
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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