Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RSP Humeral Small Socket Insert

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RSP Humeral Small Socket Insertsee related information
Date Initiated by FirmSeptember 25, 2023
Date PostedNovember 08, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0281-2024
Recall Event ID 93221
510(K)NumberK172351 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductRSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Code Information UDI-DI: 00190446257585, Lot: 954W1194
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
ActionOn 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 Commerce20
DistributionUS: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWS
-
-