Date Initiated by Firm |
October 04, 2005 |
Date Posted |
November 18, 2005 |
Recall Status1 |
Terminated 3 on May 04, 2006 |
Recall Number |
Z-0169-06 |
Recall Event ID |
33895 |
510(K)Number |
K010801
|
Product Classification |
Screw, Fixation, Bone - Product Code HWC
|
Product |
T2 System, Condyle Screw |
Code Information |
Catalog No. 1895-5085S to 1895-5120S |
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 |
3548 units |
Distribution |
nationwide |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|