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U.S. Department of Health and Human Services

Class 2 Device Recall Humeral Stem

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  Class 2 Device Recall Humeral Stem see related information
Date Initiated by Firm September 15, 2015
Date Posted October 16, 2015
Recall Status1 Terminated 3 on January 10, 2017
Recall Number Z-0131-2016
Recall Event ID 72208
510(K)Number K141990  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product AltiVate Humeral Socket Shell Trial, Part Number 804-06-052

The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.
Code Information Lot: 180052L01
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Desiree Wells
512-834-6302
Manufacturer Reason
for Recall		 Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
FDA Determined
Cause 2		 Device Design
Action The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" letter dated 9/16/15 to affected consignees/customers. The letter described the product, problem, and actions to be taken. The consignees/customers were instructed quarantine the device, pass the notice on to all who need to be aware within your organization, contact customer service to place a replacement order and receive an RMA number; and to complete a response form and return the recalled device for a replacement. If you have any questions, please call (512) 834-6302 or by email at desiree.hubby@djoglobal.com.
Quantity in Commerce 20 units
Distribution US Distribution to states of: PA, FL, ID, and CA.
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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