FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect
Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.
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 involves a structural defect in a medical device used for total hip replacement, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Omnilife Science Inc. is recalling 112 units of the APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells (Models H5-12354 and H5-11356). The recall is due to a design defect where the device may have improper screw hole placement caused by the inaccurate location of the index line.
The affected devices are intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. The recall covers specific lots: H5-12354 (Lots 20127 and 20167) and H5-11356 (Lot 20097). These devices were distributed nationwide in the United States, specifically in Illinois, Virginia, Colorado, Utah, New York, Florida, Massachusetts, Oklahoma, California, Tennessee, and Wyoming.
Healthcare providers and patients should contact Omnilife Science Inc. for further information regarding the recall and potential replacement or repair options. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
- Manufacturer
- Omnilife Science Inc.
- Affected units
- 112
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 (2)
- H5-12354: Lots - 20127 and 20167
- H5-11356: Lot - 20097
Distribution
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