Orthovita, Inc., dBA Stryker Orthobiologics.: Medical Device Recall in 2015 - (Recall #: Z-0938-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 4, 2014

Date Posted: January 14, 2015

Recall Number: Z-0938-2015

Event ID: 69979

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.

Status: Terminated

Product Quantity: 89770

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.

Voluntary or Mandated:

Voluntary: Firm initiated