Recall Z-0937-2015— Orthovita, Inc., dBA Stryker Orthobiologics.
Class II · Terminated
Class II FDA medical device recall by Orthovita, Inc., dBA Stryker Orthobiologics., initiated 2014-12-04, terminated 2015-07-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-04
- Terminated
- 2015-07-28
- Firm location
- Malvern, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.