Exactech, Inc.: Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

Is my product affected?

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

• UPC 10885862262776

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

What happened

Exactech, Inc. is recalling 98 units of Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 devices because they were labeled with incorrect Global Trade Item Numbers (GTINs). The GTIN printed on the product labels incorrectly identifies the devices as a different product. The affected devices were distributed to hospitals and medical facilities in Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee, and Virginia, as well as to Germany, Italy, Japan, Spain, and Switzerland.

The recall affects devices with specific serial numbers including 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, and 4558261-4458262, all with Catalog No. 162-00-06 and UDI 10885862262776. The source record does not specify a remedy or recommended action for affected consumers.

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

Hazard

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Details from the source

Reason for recall: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. Distribution: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland. Quantity: 98 Lot/code info: Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776

Source

Official record: FDA (Device enforcement) ↗

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

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