Manufacturer

Zimmer Trabecular Metal Technology, Inc.

11 recalls in our database name Zimmer Trabecular Metal Technology, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2019-03-20

Of the 11 recalls from Zimmer Trabecular Metal Technology, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

HighFDA (Devices)·Z-1006-2019·2019-03-20
FDA Recalls NexGen Trabecular Metal Tibial Augments Due to Labeling Mismatch
Zimmer Trabecular Metal Technology is recalling 26 units of NexGen Trabecular Metal Tibial Half Block Augments because the product in the box may not match the label.
Product
NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the kne
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1005-2019·2019-03-20
Zimmer NexGen Trabecular Metal Tibial Augment Recall for Label Mismatch
Zimmer Trabecular Metal Technology is recalling 24 units of NexGen Tibial Half Block Augments because the product in the box may not match the label.
Product
NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the kne
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1892-2017·2017-05-10
Zimmer TM Ardis Interbody System Recalled for Procedural Error in Literature Approval
Zimmer Trabecular Metal Technology, Inc. is recalling the TM Ardis Interbody System due to a procedural error in the approval of literature, resulting in the unauthorized release of certain content.
Product
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The sup
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1954-2016·2016-06-22
Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.
Product
REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1955-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.
Product
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACET
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2016·2016-06-22
Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.
Product
POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterility Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch barrier system.
Product
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, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM -
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1953-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterility Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.
Product
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 STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2016·2016-06-22
Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns
Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch sterile barrier system.
Product
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, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D, 1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1325-2015·2015-04-01
Zimmer NexGen Trabecular Metal Femoral Augment Block Mislabeled Recall
Zimmer Trabecular Metal Technology is recalling one unit of a NexGen femoral augment block that was mislabeled as 5 mm instead of 20 mm.
Product
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Kn
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0851-2015·2014-12-31
Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues
Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.
Product
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
Category
Medical Device
Distribution
0 states