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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 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
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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Colleen O'Meara
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.