Orthovita, Inc., dBA Stryker Orthobiologics. recalls Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 i

Recalled January 14, 2015 · FDA recall Z-0937-2015 · Orthovita, Inc.,

Hazard

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. · FDA Class II

Units

2155

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

Orthovita, Inc., dBA Stryker Orthobiologics.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →