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

Class 2 Device Recall Hoffman II compact Sterile Wrist Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Hoffman II compact Sterile Wrist Kit
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on September 24, 2008
Recall Number Z-2080-2008
Recall Event ID 48204
Premarket Notification
510(K) Number
K971755 
Product Classification Component, Traction, Invasive - Product Code JEC
Product Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
Code Information Catalog Number: 4940-9-810: Lot Codes: H11883, H13813, H17174, H18891, K01047, K03042, K05896.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall
Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
FDA Determined
Cause 2
DESIGN: Device Design
Action Letters were sent to Stryker branches and hospitals on August 17, 2005. If you have questions concerning this recall, contact Rita Intorrella at 201-831-5825 or Katherine Collins at 201-831-5025.
Quantity in Commerce 105 units
Distribution The product was distributed to 23 Stryker Branches, 25 hospitals and 1 government hospital nationwide
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.
510(K) Database 510(K)s with Product Code = JEC and Original Applicant = HOWMEDICA CORP.
-
-