APEX INTERFACE Hemi 54X and Flared 56X — Class II medical device recall Z-2445-2015
Terminated recall by Omnilife Science Inc., reported 2015-09-02, distributed nationwide. The device may have improper screw hole placement due to inaccurate location of the index line.
| Recall number | Z-2445-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnilife Science Inc., East Taunton, MA, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 112 |
| Lot numbers | 20097, 20127, 20167, H5-11356 |
| Model numbers | H5-11356, H5-12354 |
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.
Reason for recall
The device may have improper screw hole placement due to inaccurate location of the index line.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2445-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.