Z-0938-2015 Class II Terminated
FDA device recall Z-0938-2015 was initiated by Orthovita, Inc., dBA Stryker Orthobiologics. on December 4, 2014 and is designated Class II. 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. The recall status is terminated (terminated July 28, 2015). Affected quantity: 89770.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2015
- Initiation Date
- December 4, 2014
- Termination Date
- July 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89770
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.
Distribution Pattern
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