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.
The Internal packaging, the pouch and patient labels are improperly labeled.
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.
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.
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.
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.
Look for product codes H6-14436, H6-13928, or H6-14836 on the packaging to determine if the item is affected.
No, the recall is for improper labeling, which does not cause injury during normal use.
Check the product codes on the packaging to see if they are affected. If so, contact OMNIlife for further instructions.
Yes, lot numbers 29147, 29148, and 29778 are affected.
We’ve drafted a message you can send OMNIlife to request your refund or repair — edit it as you like.
Subject: Recall Z-2540-2018 — OMNIlife OMNIlife Hello, I own a OMNIlife that is covered by recall Z-2540-2018 from OMNIlife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
