Orthopedic Alliance LLC
Orthopedic Alliance LLC appears in FDA public data with 10 recalls, 3 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1156-2013, Class II) was initiated on March 7, 2013. Its most recent 510(k) clearance was granted on September 6, 2005.
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 3
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1156-2013 | Class II | Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR004 | March 7, 2013 |
| Z-1382-2013 | Class II | Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6m | February 20, 2013 |
| Z-1378-2013 | Class II | Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103- | February 20, 2013 |
| Z-1384-2013 | Class II | Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm | February 20, 2013 |
| Z-1383-2013 | Class II | Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, | February 20, 2013 |
| Z-1385-2013 | Class II | Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz 00 Zweimueller Type | February 20, 2013 |
| Z-1381-2013 | Class II | U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm | February 20, 2013 |
| Z-1379-2013 | Class II | Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cem | February 20, 2013 |
| Z-1386-2013 | Class II | Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CERAMIC Ball Head, 32 | February 20, 2013 |
| Z-1380-2013 | Class II | UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE | February 20, 2013 |