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U.S. Department of Health and Human Services

Class 2 Device Recall Reverse Shoulder Prosthesis (RSP)

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  Class 2 Device Recall Reverse Shoulder Prosthesis (RSP) see related information
Date Initiated by Firm August 07, 2020
Create Date September 25, 2020
Recall Status1 Open3, Classified
Recall Number Z-3021-2020
Recall Event ID 86317
510(K)Number K141006  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Code Information Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		 Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
FDA Determined
Cause 2		 Other
Action Letters were sent to the firm's Field/Sales Agents by email beginning on August 7, 2020. The letters included instructions to take the following actions by August 21, 2020: 1. Pass the notice on to all those within your organization or to any organization where the potentially affected product has been transferred, 2.Contact Customer Service at 1-800-456- 8696 to place a replacement order and receive a Return Materials Authorization (RMA) number, and to be provided with a shipping label to return the affected product. 3. Return all affected devices using the RMA number, and 4. Report any adverse events related to this issue to Customer Service. Customers with questions should contact Christine Chesnutt at 512-834-6207 or christine.chesnutt@djoglobal.com.
Quantity in Commerce 15 units
Distribution Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PHX and Original Applicant = DJO GLOBAL
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