• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

  • 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 Orthopaedics see related information
Date Initiated by Firm November 20, 2013
Date Posted February 10, 2014
Recall Status1 Open3, Classified
Recall Number Z-0964-2014
Recall Event ID 67234
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Stryker Orthopaedics Navigation Compatible Accolade Broach Handle
1 single unit to a package
Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA
Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France
Made in USA
Code Information Catalog no. 2124-1400, All lots
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
Manufacturer Reason
for Recall
Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
FDA Determined
Cause 2
Process design
Action Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013
Quantity in Commerce 211 units
Distribution IL MA, MN, ND, OR, & PA
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.