Zimmer Trabecular Metal Technology, Inc.: NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800436 Product Usage: The Trabecu

Is my product affected?

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 kn

• UPC 00889024307902

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

What happened

Zimmer Trabecular Metal Technology, Inc. is recalling 26 units of the NexGenTrabecular Metal Tibial Half Block Augment (Left Lateral/Right Medial, Size 4 5MM Thickness W/Screws, Item Number 00544800436). The products were potentially comingled during distribution, meaning the actual product inside the box may not match what is shown on the label. The recalled units were distributed worldwide, including throughout multiple U.S. states (AL, CA, CO, ID, MS, NE, NJ, NY, OH, OR, PA, TX, VA, WI) and internationally in Canada, Japan, Germany, and the Netherlands.

The affected lot numbers are 63244259, 63247617, 63279968, and 61581585T, with expiration dates of 210131, 210228, and 210228. The source document does not specify what consumers or healthcare providers should do regarding this recall.

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: 26 units Lot/code info: Lot Numbers: 63244259 63247617 63279968 61581585T (01) 00889024307902 (17) 210131 (10) 63244259 (01) 00889024307902 (17) 210228 (10) 63247617 (01) 00889024307902 (17) 210228 (10) 63279968 (01) 00889024307902 (17) 210228 (10) 61581585T

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, 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 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