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U.S. Department of Health and Human Services

Class 2 Device Recall AltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARD

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  Class 2 Device Recall AltiVate Reverse, HUMERAL SOCKET SHELL TRIAL, STANDARD see related information
Date Initiated by Firm January 30, 2018
Date Posted March 05, 2018
Recall Status1 Terminated 3 on May 30, 2023
Recall Number Z-1241-2018
Recall Event ID 79353
510(K)Number K141990  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument.

Product Usage:
The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
Code Information Lot Codes: 183312L03, 200006L01, 224643L01
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
FDA Determined
Cause 2		 Device Design
Action The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.
Quantity in Commerce 387 units
Distribution US Nationwide Distribution
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 = PHX and Original Applicant = ENCORE MEDICAL, L.P.
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