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 |
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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.
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510(K) Database | 510(K)s with Product Code = PHX
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