Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. recalled 79 units of Novation Cemented Plus Femoral Stem devices (Size 15, Collared, Standard Offset, Matte, Cemented) because the product labels contained incorrect Global Trade Item Numbers that identified the devices as a different product. The affected devices were distributed across 13 U.S. states (Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee, and Virginia) as well as internationally in Germany, Italy, Japan, Spain, and Switzerland.
The specific serial numbers involved in the recall are 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, and 4565752-4565760. The product documentation lists the Catalog Number as 160-70-15 and UDI as 10885862033086. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
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: 79 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.