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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-0167-06
Recall Event ID 33895
510(K)Number K021026  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product S2 System, Locking Screw Fully Threaded
Code Information Catalog No. 1796-5065S to 1796-5120S
Recalling Firm/
Manufacturer		 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		 Other
Action The product recall will extend to all branches.agencies and hospitals that have received the product.
Quantity in Commerce 2465 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.
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