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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm December 27, 2004
Date Posted January 15, 2005
Recall Status1 Terminated 3 on March 18, 2005
Recall Number Z-0401-05
Recall Event ID 30759
510(K)Number K993166  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm
Part Numbers: 234-010-078; 234-010-080
Code Information Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
The label on the outside of the shipping box has an incorrect description of the screw diameter.
FDA Determined
Cause 2
Action Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.
Quantity in Commerce 16 units of 078, 284 units of 080
Distribution 6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.
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 = Stryker Endoscopy