Apex ARC Hip Stem — Class II medical device recall Z-2064-2015
Terminated recall by Omnilife Science Inc., reported 2015-07-22, distributed nationwide. Product may breach the inner and outer sterile pouches during shipping or handling.
| Recall number | Z-2064-2015 |
|---|---|
| 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 | 2015-06-03 |
| Classified | 2015-07-14 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2015-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 146 devices |
| Reason classes | sterility |
| Lot numbers | 18070, 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688 |
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. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Reason for recall
Product may breach the inner and outer sterile pouches during shipping or handling.
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-2064-2015. 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.