Recall record at a glance
| Official record | Z-2540-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | OMNIlife science Inc. |
| Report date | Aug 1, 2018 |
| Recall initiation date | May 18, 2018 |
| Quantity | 16 units |
| Location | Raynham, MA, United States |
Official product description
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed
Why the product was recalled
The Internal packaging, the pouch and patient labels are improperly labeled.
Distribution information
US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.