Z-0937-2015 Class II Terminated
FDA device recall Z-0937-2015 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 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle. The recall status is terminated (terminated July 28, 2015). Affected quantity: 2155.
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.