Zimmer Trabecular Metal Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 13
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1006-2019 | Class II | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W | February 1, 2019 |
| Z-1005-2019 | Class II | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W | February 1, 2019 |
| Z-1892-2017 | Class III | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion | July 7, 2016 |
| Z-1953-2016 | Class II | TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR | April 15, 2016 |
| Z-1950-2016 | Class II | POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATEL | April 15, 2016 |
| Z-1954-2016 | Class II | REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER | April 15, 2016 |
| Z-1951-2016 | Class II | TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 | April 15, 2016 |
| Z-1952-2016 | Class II | TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ | April 15, 2016 |
| Z-1955-2016 | Class II | 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 | April 15, 2016 |
| Z-1325-2015 | Class II | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. | February 4, 2015 |
| Z-0851-2015 | Class II | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size | December 2, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133784 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION | July 7, 2014 |
| K123602 | TM ARDIS INTERBODY SYSTEM INSERTER | March 1, 2013 |
| K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL | June 29, 2012 |
| K120203 | TM-400 DEVICE | June 15, 2012 |
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION | May 29, 2012 |
| K111983 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX | November 18, 2011 |
| K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | February 15, 2011 |
| K103033 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX | January 10, 2011 |
| K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | December 13, 2010 |
| K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET | March 4, 2010 |
| K070754 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 | August 31, 2007 |
| K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | June 29, 2007 |
| K070382 | VISTA -S DEVICE | May 30, 2007 |