Exactech Recalls Mislabeled Optetrak Femoral Implants
Exactech, Inc. is voluntarily recalling 96 Optetrak femoral implants due to mislabeling. The devices were distributed internationally to 13 countries.
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 due to mislabeling, which fits the rubric for minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Exactech, Inc. is voluntarily recalling 96 units of Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3. The recall was initiated because the products were mislabeled. The affected catalog numbers are #244-02-03 and #244-03-03, with specific serial number ranges provided in the official notice.
The recalled devices are femoral implants intended for medical use. They were distributed internationally to Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain, and Tunisia. The recall was initiated on October 9, 2014, and was classified as Class II by the FDA. The recall status is currently terminated.
Healthcare providers and patients who have received these specific implants should contact Exactech, Inc. or their local FDA office for further instructions. The recall was initiated by the firm and notified via letter.
The recalled product
- Product
- Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 96
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 (4)
- Catalog #244-02-03
- Serial # 2925147 - 2925194
- Catalog #244-03-0
- Serial #2925246 - 2925293.
Distribution
Distribution scope not specified by the agency.
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