Orthovita, Inc., dBA Stryker Orthobiologics.: Medical Device Recall in 2015 - (Recall #: Z-0937-2015)

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 Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.

Product Classification:

Class II

Date Initiated: December 4, 2014

Date Posted: January 14, 2015

Recall Number: Z-0937-2015

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 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.

Status: Terminated

Product Quantity: 2155

Code Information:

all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated