OMNIlife Hip System Recalls Improperly Labeled Packaging
OMNIlife recalls hip implants with improperly labeled packaging. Affected products include Apex-LNK Acetabular Inserts for hip replacements. Consumers should check product codes and lot numbers for affected items.
Lower-risk recall
The Internal packaging, the pouch and patient labels are improperly labeled.
Contact the company
What happened, in plain English
OMNIlife is recalling hip implants that have improperly labeled packaging. This issue could lead to confusion about the product's use, but it does not pose a direct safety risk to users. Read more at govinfonow.com/recall/71034-omnilife-hip-system-recalls-improperly-labeled-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/71034-omnilife-hip-system-recalls-improperly-labeled-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2540-2018
Cite this page
“OMNIlife Hip System Recalls Improperly Labeled Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/71034-omnilife-hip-system-recalls-improperly-labeled-packaging. Based on FDA recall #Z-2540-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2018%22&limit=1).
Why it’s dangerous
The packaging, pouches, and patient labels for these hip implants are labeled incorrectly. This could cause confusion about the product's intended use, but it does not involve a physical hazard that could cause injury during normal use.
Who’s affected
Patients who received the Apex Hip System implants with product codes H6-14436, H6-13928, or H6-14836 are likely affected. Those who have undergone hip replacement surgery with these specific implants are at the highest risk.
How to tell if you have this one
Check for product codes H6-14436, H6-13928, or H6-14836 on the packaging. The affected implants were sold with lot numbers 29147, 29148, or 29778.
- Brand
OMNIlife- Category
Medical device
What to do — step by step
Check Product Labels
Look for product codes H6-14436, H6-13928, or H6-14836 on the packaging to determine if the item is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Florida, Illinois, Massachusetts.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2540-2018 (May 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2540-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.