Orthovita, Inc., dBA Stryker Orthobiologics.

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2772-2015Class IIAliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitatAugust 20, 2015
Z-1353-2015Class IIVitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunctFebruary 26, 2015
Z-0937-2015Class IIStryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled NeDecember 4, 2014
Z-0938-2015Class IIStryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bulleDecember 4, 2014
Z-1398-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, November 10, 2012
Z-1395-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", PartNovember 10, 2012
Z-1392-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", PaNovember 10, 2012
Z-1390-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe DeliveryNovember 10, 2012
Z-1391-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, November 10, 2012
Z-1394-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, November 10, 2012
Z-1393-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", ParNovember 10, 2012
Z-1389-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger DeliveryNovember 10, 2012
Z-1387-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger DeliveryNovember 10, 2012
Z-1396-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", PartNovember 10, 2012
Z-1397-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", ParNovember 10, 2012
Z-1399-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", PaNovember 10, 2012
Z-1388-2013Class IIStryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger DeliveryNovember 10, 2012