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Terminated

Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

FDA Recall Z-2241-2014 · Posted 2014-08-15

Recalling FirmOmnilife Science Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2014-05-09
Date Terminated2014-08-19
Product Quantity13 devices

Reason for Recall

Staining on hip implant.

Firm Action

All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science.

Root Cause

Manufacturing material removal

Distribution Pattern

US: CA, OK, VA, FL, MA, NY, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090845APEX ARC HIP STEMOmni Life Science, Inc. · 2010-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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