Class 2 Device Recall Linear Hip Neck Trials

• Date Initiated by Firm: June 21, 2016
• Date Posted: July 19, 2016
• Recall Status: Terminated 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
• Product: MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
• Code Information: Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Neeta Sharma; 512-832-9500
• 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: 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.