Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bu...
FDA Recall #Z-0938-2015 — Class II — December 4, 2014
Product Description
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.
Reason for Recall
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.
Recalling Firm
Orthovita, Inc., dBA Stryker Orthobiologics. — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
89770
Distribution
Worldwide Distribution: US (nationwide) and country of: Canada.
Code Information
all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated