On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects
On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.
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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
On-X Life Technologies, Inc. is recalling 45 units of the Chord-X Chordal Sizer. This medical device is designed to assist surgeons in determining the proper length of chordal replacement prostheses for mitral valve repair. The recall was initiated after the firm's corrective and preventive action (CAPA) process identified four specific manufacturing issues.
The identified defects include the presence of burrs on the Left Housing, Right Housing, and Barrel components; loose plastic particulate within sealed primary packages; loose hair discovered in four sealed primary packages; and an assembly error in one sealed primary package where a Left Housing press-fit pin was not fully inserted, resulting in a small gap in the housing assembly.
The affected units were distributed to facilities in California, Washington, Nebraska, Delaware, Ohio, Maine, and Texas. The source text does not specify the exact number of patients affected or report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve…
- Manufacturer
- On-X Life Technologies, Inc.
- Affected units
- 45
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 (1)
- 72-00-47420
Distribution
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