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 CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10 TILT 32mm

  • 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 CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10 TILT 32mm see related information
Date Initiated by Firm August 08, 2023
Date Posted January 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-0843-2024
Recall Event ID 93729
510(K)Number K191146  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Code Information UDI-DI: 03701037309551, Lot: U0191
Recalling Firm/
Manufacturer		 FX SHOULDER
13465 Midway Rd Ste 310
Dallas TX 75244-5183
For Additional Information Contact Matt Glaser
800-429-8965
Manufacturer Reason
for Recall		 Centered glenosphere box may contain an eccentric glenosphere.
FDA Determined
Cause 2		 Labeling mix-ups
Action On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm.
Quantity in Commerce 4
Distribution US Nationwide distribution in the state of NJ.
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 = FX Shoulder USA, Inc.
-
-