Zimmer Trabecular Metal Technology recalls
Zimmer Trabecular Metal Technology appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2019-03-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 11 |
|---|---|
| Published | 2014-12-31 to 2019-03-20 |
| By agency | FDA Device (11) |
| By classification | Class II (10), Class III (1) |
| By status | terminated (11) |
| Distribution named in notices | CA, US |
Recalls
- NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product…
FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology
Reason: Potentially comingled, resulting in the product in the box potentially not matching the product on the label - NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product…
FDA Device · Class II · 2019-03-20 · Zimmer Trabecular Metal Technology
Reason: Potentially comingled, resulting in the product in the box potentially not matching the product on the label - The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine
FDA Device · Class III · 2017-05-10 · Zimmer Trabecular Metal Technology
Reason: This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and… - 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 A…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - 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 TIB…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - 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 SZ 3 C/D…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - 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 SZ 3 C-H, 17…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology
Reason: Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to… - NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only
FDA Device · Class II · 2015-04-01 · Zimmer Trabecular Metal Technology
Reason: One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. - NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, U…
FDA Device · Class II · 2014-12-31 · Zimmer Trabecular Metal Technology
Reason: During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.