Recall Z-2445-2015— Omnilife Science Inc.

Name: FDA recall Z-2445-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Omnilife Science Inc., initiated 2015-06-04, terminated 2015-09-28. It names one FDA 510(k) clearance: K112779. 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: The device may have improper screw hole placement due to inaccurate location of the index line..

Recalling firm: Omnilife Science Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2015-09-28
Firm location: East Taunton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112779 — APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)Omnlife Science·cleared 2011-12-02

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 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.

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