Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating
Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 10 units of the NOVATION Femoral Stem, Tapered Extended offset, plasma-coated, press fit (Catalog number 160-01-13). The recall is due to the femoral stems lacking the specified plasma coating. These devices are intended to be implanted to replace a hip joint with or without bone cement.
The affected units have serial numbers 2910243 through 2910252. The devices were distributed worldwide, including in Spain, Greece, and Japan.
Consumers and healthcare providers should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 10
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 (10)
- Serial Numbers: 2910243
- 2910244
- 2910245
- 2910246
- 2910247
- 2910248
- 2910249
- 2910250
- 2910251
- and 2910252
Distribution
Distribution scope not specified by the agency.
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