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 stryker ORTHOLOC

  • 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 stryker ORTHOLOC see related information
Date Initiated by Firm April 10, 2023
Date Posted April 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-1466-2023
Recall Event ID 92078
510(K)Number K120359  
Product Classification Plate, fixation, bone - Product Code HRS
Product stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Code Information UDI/DI 00889797101011, Lot Number 1736809
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
Manufacturer Reason
for Recall		 Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
FDA Determined
Cause 2		 Employee error
Action The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its sales representatives and distributors on 04/10/2023 by email and followed with letters disseminated to the remaining consignees via tracked FedEx mailing on Wednesday, April 12. The notice explained the issue and the risk and requested the following actions be taken: Identify all affected products and isolate/quarantine to prevent accidental use. All parties that further distributed the product were directed to notify anyone to the recipients of the affected products. The firm is seeking return of the products.
Quantity in Commerce 41 units
Distribution US Nationwide distribution.
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 = HRS and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
-
-