Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shellssee related information
Date Initiated by FirmJune 04, 2015
Date PostedAugust 21, 2015
Recall Status1 Terminated 3 on September 28, 2015
Recall NumberZ-2445-2015
Recall Event ID 71461
510(K)NumberK112779 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductAPEX 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.
Code Information H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097
Recalling Firm/
Manufacturer		 Omnilife Science Inc.
50 Oconnell Way Ste 10
East Taunton MA 02718-1394
For Additional Information ContactMatthew Nowland
774-226-1841
Manufacturer Reason
for Recall		The device may have improper screw hole placement due to inaccurate location of the index line.
FDA Determined
Cause 2		Process design
ActionOmni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
Quantity in Commerce112
DistributionUS Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPH
-
-