FDA-Device2015-01-14Class II
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.
Orthovita, Inc., dBA Stryker Orthobiologics.
Hazard
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.
Sold states
Worldwide Distribution: US (nationwide) and country of: Canada.
Affected count
89770
Manufactured in
45 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2015Don't want to check this manually?
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