Z-0937-2015 Class II Terminated
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
- 2155
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.
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.
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: Canada.
Code Information
all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.