Zimmer Trabecular Metal Technology, Inc.: NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecu

Is my product affected?

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 knee joint indicates total kn

• UPC 00889024307858

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Trabecular Metal Technology, Inc. is recalling 24 units of NexGenTrabecular Metal Tibial Half Block Augment (Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws, Item Number 00544800426) due to a comingling issue where the product inside the box may not match the product labeled on the outside. The affected lot numbers are 63253751, 63257915, and 63291542. The product was distributed worldwide, including throughout the United States in Alabama, California, Colorado, Idaho, Mississippi, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, and Wisconsin, as well as in Canada, Japan, Germany, and the Netherlands.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potentially comingled, resulting in the product in the box potentially not matching the product on the label Distribution: Worldwide Distribution - US Nationwide Distribution in the states of AL, CA, CO, ID, MS,NE, NJ, NY, OH, OR, PA, TX, VA, WI and Foreign CANADA, JAPAN, GERMANY , NETHERLANDS Quantity: 24 units Lot/code info: Lot Numbers: 63253751 63257915 63291542 UDI: (01) 00889024307858 (17) 210228 (10) 63253751 (01) 00889024307858 (17) 210228 (10) 63257915 (01) 00889024307858 (17) 210430 (10) 63291542

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 kn2019-02-01
• Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.2019-01-28
• Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.2019-02-06
• Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.2019-02-06
• Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.2019-02-08

All FDA (Device enforcement) recalls