Orthovita, Inc., dBA Stryker Orthobiologics. recalls Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4…

Recall date

December 4, 2014

Source

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

Recall number

Z-0938-2015

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 Imbibe Bone Marrow Aspiration 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 Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.