• 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 Posted February 10, 2014
Recall Status1 Open
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
non-sterile
Code Information Catalog no. 2124-1400
All lots
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
201-831-5000
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-