FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining
Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a surface defect (staining) on a medical device, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Apex Arc Hip Stem, Size 2, HA Coated (Product Code: HC-21002-HA). The recall is being conducted by the manufacturer, Omnilife Science Inc., due to staining observed on the hip implant.
The recall affects 13 devices from Lot 17284. These devices were distributed to facilities in California, Oklahoma, Virginia, Florida, Massachusetts, New York, and Texas.
Healthcare providers and patients should contact Omnilife Science Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
- Manufacturer
- Omnilife Science Inc.
- Hazard
- Affected units
- 13
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)
- Lot: 17284
Distribution
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