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U.S. Department of Health and Human Services

Class 2 Device Recall RSP Humeral Socket Insert

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  Class 2 Device Recall RSP Humeral Socket Insert see related information
Date Initiated by Firm September 25, 2023
Date Posted November 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-0282-2024
Recall Event ID 93221
510(K)Number K051075  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Code Information UDI-DI: 00888912144667, Lot: 390P1157
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		 Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
FDA Determined
Cause 2		 Labeling Change Control
Action On 09/25/23, recall notices were emailed to Agents who were asked to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred. 2) Return all affected devices using the RMA number. 3) Complete and return the response form. Questions can be directed to livia.kuruvila@enovis.com
Quantity in Commerce 20
Distribution US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, 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 = ENCORE MEDICAL, L.P.
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