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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/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Customer Service
800-624-4422
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		 Other
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
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