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Recall Observatory FDA recall evidence

Device product

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

Z-1032-2017

November 07, 2016

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 75989
Status
Terminated
Classification
Class II
Quantity
98
Official record key
device-enforcement:Z-1032-2017

Official wording

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

Code information: Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776

Distribution pattern: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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