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U.S. Department of Health and Human Services

Class 2 Device Recall Reverse Shoulder System e, RSP Humeral Socket Insert

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  Class 2 Device Recall Reverse Shoulder System e, RSP Humeral Socket Insert see related information
Date Initiated by Firm October 05, 2023
Date Posted January 02, 2024
Recall Status1 Completed
Recall Number Z-0625-2024
Recall Event ID 93623
510(K)Number K051075  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Code Information UDI: (01)00888912144612/Lot Number(s): 381P1167
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact Julie Zorka
512-832-9500
Manufacturer Reason
for Recall		 Mislabeling
FDA Determined
Cause 2		 Packaging process control
Action On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your 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. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 17 units
Distribution US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, 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.
510(K) Database 510(K)s with Product Code = PHX and Original Applicant = ENCORE MEDICAL, L.P.
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