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U.S. Department of Health and Human Services

Class 2 Device Recall RSP Glenoid Baseplate

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  Class 2 Device Recall RSP Glenoid Baseplate see related information
Date Initiated by Firm September 06, 2023
Date Posted December 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-0532-2024
Recall Event ID 93428
510(K)Number K112069  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Code Information Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Sherri Mellingen
512-834-6200
Manufacturer Reason
for Recall		 Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
FDA Determined
Cause 2		 Component design/selection
Action On 9/6/2023, the firm sent an email, "SE190 URGENT PLEASE READ-QUARANTINE NOTICE" stating that "identified a potential issue" with the RSP BASEPLATE, 30MM, W/P2 COATING". This email instructed customers to "Please reply all to this email when you've located the part(s) and have it quarantined. We will provide further instruction as soon as possible. Please do not request an RMA at this time". On 11/10/2023, the firm sent via email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the RSP Glenoid Baseplate was found to have an undersized hex, preventing engagement with the Straight Mod Hexdriver and /or Hex Head Screw Driver. Customers were instructed to: 1. Pass this notice to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. The customer will be provided with a shipping label to return the affected product. For questions, contact Livia Kuruvila at (914)450-3931 or by email at livia.kuruvila@enovis.com
Quantity in Commerce 146 units
Distribution U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None
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 = ENCORE MEDICAL, L.P.
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