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Zimmer Trabecular Metal Technology, Inc.

Complete recall history across all FDA and CPSC categories — 11 total recalls

Zimmer Trabecular Metal Technology, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (11)

FDA medical device enforcement actions by Zimmer Trabecular Metal Technology, Inc.

Date Product Reason Class
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... Potentially comingled, resulting in the product in the box potentially not ma... Class II
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... Potentially comingled, resulting in the product in the box potentially not ma... Class II
Jul 7, 2016 The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... This field action is being initiated following the firm's discovery of a proc... Class III
Apr 15, 2016 POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Apr 15, 2016 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,2... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Apr 15, 2016 REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 007010050... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Apr 15, 2016 TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Apr 15, 2016 TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Apr 15, 2016 TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, steril... Class II
Feb 4, 2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequentl... Class II
Dec 2, 2014 NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibi... During cleaning, two separate units of the NexGen Tibial Base plates did not ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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