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U.S. Department of Health and Human Services

Class 2 Device Recall Hoffman II compact Sterile Wrist Kit

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  Class 2 Device Recall Hoffman II compact Sterile Wrist Kit see related information
Date Initiated by Firm August 17, 2005
Date Posted September 16, 2008
Recall Status1 Terminated 3 on September 24, 2008
Recall Number Z-2080-2008
Recall Event ID 48204
510(K)Number K971755  
Product Classification Invasive traction component - 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 NJ 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		 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JEC and Original Applicant = HOWMEDICA CORP.
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