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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells see related information
Date Initiated by Firm June 04, 2015
Date Posted August 21, 2015
Recall Status1 Terminated 3 on September 28, 2015
Recall Number Z-2445-2015
Recall Event ID 71461
510(K)Number K112779  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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.
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 Contact Matthew 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
Action Omni 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 Commerce 112
Distribution US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LPH and Original Applicant = OMNLIFE SCIENCE
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