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

Agency Publication Date: January 17, 2017

Affected Products

Product: Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086

Product: AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

Serial No. 4507932-4507943; Catalog No. 138-36-29; UDI: 10885862024831

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75989

Status: Resolved

Manufacturer: Exactech, Inc.

Manufactured In: United States

Units Affected: 3 products (79 units; 12 devices; 98)

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Sources: FDA iRES · Raw API Response

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