Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk
Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.
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 medical device where a sterile barrier breach could lead to infection, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Omnilife Science Inc. is recalling 146 units of the Apex ARC Hip Stem, HA Coated, Size 5 (Product Code: HC-21005-HA). These devices are femoral components intended for primary or revision total hip replacement and are manufactured from titanium alloy with a hydroxyapatite coating.
The recall is being conducted because the product may breach the inner and outer sterile pouches during shipping or handling. This potential breach could compromise the sterile status of the device. The affected lot numbers are 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, and 18070.
The devices were distributed nationwide in the United States, specifically in the states of Utah, California, Florida, Texas, Massachusetts, Georgia, Oklahoma, Virginia, Connecticut, and Wyoming. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use.…
- Manufacturer
- Omnilife Science Inc.
- Affected units
- 146
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 (11)
- Lot Numbers: 5679
- 5777
- 7420
- 7588
- 7787
- 8369
- 8605
- 8869
- 9485
- 9688
- 18070
Distribution
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