Orthopedic Alliance LLC

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
3
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1156-2013Class IIOrthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR004March 7, 2013
Z-1382-2013Class IIFemoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mFebruary 20, 2013
Z-1378-2013Class IIFemoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-February 20, 2013
Z-1384-2013Class IICo-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mmFebruary 20, 2013
Z-1379-2013Class IITibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemFebruary 20, 2013
Z-1381-2013Class IIU2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm February 20, 2013
Z-1385-2013Class IIZweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller TypeFebruary 20, 2013
Z-1383-2013Class IIBipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, February 20, 2013
Z-1386-2013Class IIBall Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32February 20, 2013
Z-1380-2013Class IIUKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE February 20, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K052237SC CERAMIC BALL HEADSSeptember 6, 2005
K033826ORTHOPEDIC ALLIANCE SPINE SYSTEMJuly 1, 2004
K031474SC TOTAL HIP SYSTEMOctober 15, 2003