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