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U.S. Department of Health and Human Services

Class 3 Device Recall Biosteon

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  Class 3 Device Recall Biosteon see related information
Date Initiated by Firm August 23, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0165-06
Recall Event ID 33186
510(K)Number K021351  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Biosteon brand HA/PLLA Cross Pin,
Model Number 234-500-350;
Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138
Code Information 04/05-PH134
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Carlos Gonzalez
408-754-2179
Manufacturer Reason
for Recall		 The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.
FDA Determined
Cause 2		 Other
Action On 8/23/05, all consignees were notified via telephone, written letter and also via sales representative, informing them of the affected product and providing instructions on the recall.
Quantity in Commerce 495 units
Distribution The product was distributed nationally to 8 consignees and internationally to 12 consignees via distributors and directly to physicians and/or medical facilities. Foreign countries include, Canada, Poland and Italy. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and medical facilities who received the recalled product.
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 = BIOCOMPOSITES LTD.
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