Orthovita, Inc., dBA Stryker Orthobiologics. recalls Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4…

Recall date

December 4, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0937-2015

FDA classification

Class II

Brand / firm

Orthovita, Inc., dBA Stryker Orthobiologics.

Sold / distributed

Worldwide Distribution: US (nationwide) and country of: Canada.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.