Recall Z-2241-2014— Omnilife Science Inc.

Name: FDA recall Z-2241-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-09

Class II · Terminated

Class II FDA medical device recall by Omnilife Science Inc., initiated 2014-05-09, terminated 2014-08-19. It names one FDA 510(k) clearance: K090845. Product: Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA. Reason: Staining on hip implant..

Recalling firm: Omnilife Science Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Terminated: 2014-08-19
Firm location: East Taunton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K090845 — APEX ARC HIP STEMOmni Life Science, Inc.·cleared 2010-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Staining on hip implant.

Data sourced from openFDA. This site is unofficial and independent of the FDA.