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U.S. Department of Health and Human Services

Class 2 Device Recall Linear Hip Neck Trials

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  Class 2 Device Recall Linear Hip Neck Trials see related information
Date Initiated by Firm June 21, 2016
Date Posted July 19, 2016
Recall Status1 Terminated 3 on January 10, 2017
Recall Number Z-2242-2016
Recall Event ID 74484
510(K)Number K974294  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Code Information Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Neeta Sharma
Manufacturer Reason
for Recall
Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
FDA Determined
Cause 2
Process design
Action The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.
Quantity in Commerce 14 (7 sets)
Distribution CO, ID, TX
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 = ENCORE ORTHOPEDICS, INC.