Offset Femoral Alignment Guide 4mm x 6¿ — Class II medical device recall Z-2455-2015
Terminated recall by Omnilife Science Inc., reported 2015-09-02, distributed nationwide. The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings
| Recall number | Z-2455-2015 |
|---|---|
| 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 | 2015-06-09 |
| Classified | 2015-08-24 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2015-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, ES |
| Quantity | 15 |
| Lot numbers | MM0314R, VA0713, Z1111 |
Product
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Reason for recall
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
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-2455-2015. 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.