Devices

Device Recall Imbibe Aliquot Needle Bone Cement Needle

Model / Serial
all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and country of: Canada.
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.
Manufacturer
Orthovita, Inc., dBA Stryker Orthobiologics.
1 Event
- Recall of Device Recall Imbibe Aliquot Needle Bone Cement Needle

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer Address
Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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