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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 04, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on May 04, 2006
Recall Number Z-0166-06
Recall Event ID 33895
510(K)Number K021026  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product S2 System, Locking Screw Partially Threaded
Code Information Catalog No. 1791-5065S to 1791-5120S
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Dominick Cristofolo
201-831 Ext. 5247
Manufacturer Reason
for Recall
Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
FDA Determined
Cause 2
Action The product recall will extend to all branches.agencies and hospitals that have received the product.
Quantity in Commerce 171 units
Distribution 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 = HWC and Original Applicant = HOWMEDICA OSTEONICS CORP.