Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Zimmer Trabecular Metal Technology with 13 510(k) clearances and 11 device recalls. The most recent is a device recall dated Feb 1, 2019: NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 ProClass II · Potentially comingled, resulting in the product in the box potentially not matching the product on the label | Device recalls |
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 ProClass II · Potentially comingled, resulting in the product in the box potentially not matching the product on the label | Device recalls |
| Jul 7, 2016 | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TMClass III · This field action is being initiated following the firm's discovery of a procedural error in the approval of literature | Device recalls |
| Apr 15, 2016 | TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB Class II · Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manuf | Device recalls |
| Apr 15, 2016 | TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TClass II · Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manuf | Device recalls |
| Apr 15, 2016 | TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZClass II · Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manuf | Device recalls |
| Apr 15, 2016 | REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LIClass II · Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manuf | Device recalls |
| Apr 15, 2016 | 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504Class II · Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manuf | Device recalls |
| Jul 7, 2014 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATIONK133784 · ODP | 510(k) clearances |
| Mar 1, 2013 | TM ARDIS INTERBODY SYSTEM INSERTERK123602 · MAX | 510(k) clearances |
| Jun 29, 2012 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIALK120990 · MBH | 510(k) clearances |
| Jun 15, 2012 | TM-400 DEVICEK120203 · MAX | 510(k) clearances |
| May 29, 2012 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATIONK113561 · MAX | 510(k) clearances |
| Nov 18, 2011 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXXK111983 · ODP | 510(k) clearances |
| Feb 15, 2011 | TRABECULAR METAL FEMORAL CONE AUGMENTSK103517 · MBH | 510(k) clearances |
| Jan 10, 2011 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXXK103033 · ODP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
