Exactech Recalls Alteon HA Femoral Stems Due to Labeling Error
Exactech is recalling 34 Alteon HA Femoral Stems because the labels incorrectly described the device. The units were distributed to five US states.
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 involves a labeling error (wrong device description) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling 34 units of the Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5. The recall was initiated because the label on the device provided the wrong description of the implant.
The affected devices are identified by Catalog # 190-30-05 and specific serial numbers listed in the agency record. These hip replacement components are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement.
The recalled units were distributed to the states of Alabama, California, Colorado, Florida, Maryland, and New York. Consumers and healthcare providers should verify the serial numbers of their devices against the recall list and contact Exactech or the FDA for further instructions.
The recalled product
- Product
- Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 34
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 (20)
- Catalog #: 190-30-05 Serial#'s: 4897288
- 4897291
- 4897293
- 4907465
- 4907466
- 4907467
- 4907469
- 4907472
- 4907475
- 4907476
- 4907477
- 4907478
- 4907479
- 4907481
- 4943094
- 4943095
- 4943096
- 4943097
- 4943102
- 4943104
Distribution
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