FDA Device recall Z-1006-2019

NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product…

• FDA Device
• Class II
• terminated
• Published 2019-03-20

On 2019-03-20 the FDA classified a Class II recall of NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product… by Zimmer Trabecular Metal Technology, citing potentially comingled, resulting in the product in the box potentially not matching the product on the label.

Read the official FDA Device notice

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 knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments are for cementless or cemented use.

Reason

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Other recalls by Zimmer Trabecular Metal Technology

• 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
• 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
• 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
• 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
• 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

All Zimmer Trabecular Metal Technology recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2019%22

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