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U.S. Department of Health and Human Services

Class 2 Device Recall Trial Shell component of the accessory kit to the Shoulder Prosthesis Stem

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  Class 2 Device Recall Trial Shell component of the accessory kit to the Shoulder Prosthesis Stem see related information
Date Initiated by Firm December 08, 2015
Date Posted January 09, 2016
Recall Status1 Terminated 3 on March 01, 2016
Recall Number Z-0626-2016
Recall Event ID 72809
510(K)Number K141990  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Code Information 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Teffany Hutto
512-834-6255
Manufacturer Reason
for Recall
The trial shell mating feature on the broach is undersized.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The recalling firm notified customers of the recall via letter on 12/8/15.
Quantity in Commerce 23 units
Distribution Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, 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 = PHX and Original Applicant = ENCORE MEDICAL, L.P.
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