Device product

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.

Z-0938-2015

December 04, 2014

Class II

Product summary

Firm: Orthovita, Inc., dBA Stryker Orthobiologics.
Event: Event 69979
Status: Terminated
Classification: Class II
Quantity: 89770
Official record key: device-enforcement:Z-0938-2015

Official wording

Reason: There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.

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

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.