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 Tornier Perform Reversed Glenoid PressFit Short Post

  • 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 Tornier Perform Reversed Glenoid PressFit Short Post see related information
Date Initiated by Firm January 03, 2024
Date Posted January 19, 2024
Recall Status1 Open3, Classified
Recall Number Z-0773-2024
Recall Event ID 93709
510(K)Number K183696  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Code Information Batch lot codes 6714AZ, serial numbers 001 to 050: 6714AZ001, 6714AZ002, 6714AZ003, 6714AZ004, 6714AZ005, 6714AZ006, 6714AZ007, 6714AZ008, 6714AZ009, 6714AZ010, 6714AZ011, 6714AZ012, 6714AZ013, 6714AZ014, 6714AZ015, 6714AZ016, 6714AZ017, 6714AZ018, 6714AZ019, 6714AZ020, 6714AZ021, 6714AZ022, 6714AZ023, 6714AZ024, 6714AZ025, 6714AZ026, 6714AZ027, 6714AZ028, 6714AZ029, 6714AZ030, 6714AZ031, 6714AZ032, 6714AZ033, 6714AZ034, 6714AZ035, 6714AZ036, 6714AZ037, 6714AZ038, 6714AZ039, 6714AZ040, 6714AZ041, 6714AZ042, 6714AZ043, 6714AZ044, 6714AZ045, 6714AZ046, 6714AZ047, 6714AZ048, 6714AZ049, 6714AZ050; GTIN 00846832091614.
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 The incorrect device is contained in the labeled package.
FDA Determined
Cause 2		 Packaging process control
Action The recalling firm issued letters dated 1/3/2024 via email to sales representatives and distributors and via FedEx to hospitals on 1/3/2024. The letter provided a product description, product issue, potential risks including a photo of the device that should be in the package and a photo of the device that was in the package. The customer actions needed included: (1) Immediately check the inventory for the affected product, remove it from the point of use, and isolate/quarantine it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email to confirm receipt of the notification; (3) Upon receipt of the completed Business Reply Form, the firm will contact the customer to arrange for return of the product; (4) If the product has been further distributed, notify the applicable parties at once about the recall. If possible, inform the recalling firm if any of the devices have been distributed to other organizations, including contact details. If the letter recipient is a distributor, they are responsible for notifying their affected customers.
Quantity in Commerce 50
Distribution Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.
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 = Tornier, Inc.
-
-