Exactech Recalls Novation Cemented Plus Femoral Stems Due to Labeling Error
Exactech is recalling 79 Novation Cemented Plus Femoral Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect GTIN) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Exactech, Inc. is recalling 79 units of the Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15. The recall was initiated because the products were labeled with incorrect Global Trade Item Numbers (GTINs). The GTIN on the label identifies the devices as a different product.
The affected devices were distributed in Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee, and Virginia, as well as in Germany, Italy, Japan, Spain, and Switzerland. The specific serial numbers involved are 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, and 4565752-4565760. The catalog number is 160-70-15 and the UDI is 10885862033086.
Healthcare providers and facilities should check their inventory for these specific serial numbers. If the devices are found, they should be removed from use and returned to Exactech, Inc. according to the company's instructions.
The recalled product
- Product
- Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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